Annual Report����

RECOGNISING OUTSTANDING LEADERSHIP

I am honoured to be a recipient of this award and grateful to have been recognised by this group of dedicated medical health professionals. It is a great privilege to contribute to improving treatments for patients, working together to make a real difference for those affected by GI cancer.

Professor John SimesJohn Zalcberg OAM Award for Excellence in AGITG Clinical Trials Research

Vision: Our aim is to create a world free from gastro-intestinal cancers. Mission: We put patients with gastro-intestinal cancer at the centre of our research, saving and improving lives by accelerating the pace of discoveries that lead to cures. Our dedicated group of research and health professionals translate bold new ideas into life-saving clinical trials that help those patients as quickly as possible.

2 The Year at a Glance5 About Us6 Next Generation Researchers9 AGITG Research Priorities10 Our Global Presence13 Our Members15 Chair’s Message16 Chief Executive Officer’s Report20 Group Coordinator’s Report23 Consumer Advisory Panel Report24 Funding Gastro-Intestinal Cancer Research26 Clinical Trials29 Oesophageal Cancer30 Stomach Cancer, GIST & NETs33 Pancreatic, Gallbladder & Biliary Tract Cancer34 Colorectal & Anal Cancer37 Translational Research39 Journal Publications & Conference Presentations 43 Genesis of a Clinical Trial44 Annual Scientific Meeting48 Investing in Research52 Grants54 Board of Directors59 Organisational Structure60 Scientific Advisory Committee & Working Parties 63 Treasurer’s Report64 Income Statement65 Balance Sheet66 Your Support Makes the Difference68 GI Cancer Institute Sponsors

Pictured Front Cover (L-R): Showcasing the next generation of researchers. Dr Howard Chan is a medical oncologist at Macarthur Cancer Therapy Centre and was an AGITG Research Fellow in 2015, Dr Monica Tang is a Medical Oncology Fellow at St George Hospital and was an AGITG Research Fellow in 2017, Dr Sayeda Naher is the 2018 AGITG Research Fellow, Dr Elizabeth Connolly is a medical oncologist at Calvary Mater Newcastle, Dr Christina Teng is a medical oncologist and an investigator on the AGITG OXTOX trial, Dr Sarah Maloney is an advanced radiation oncology trainee at St Vincent’s HospitalPictured Back Cover (L-R): Professor John Simes is a retired AGITG Director and Group Coordinator, Dr Lorraine Chantrill is an AGITG Director and Chair of the Upper GI Working Party, Professor Tim Price is Chair of the AGITG and the Scientific Advisory Committee, Associate Professor Niall Tebbutt is an AGITG Director and Chair of the Lower GI Working Party

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The Year at a Glance

1. January• Miles Gray, pictured, shaves his

head and raises funds for research in memory of his friend & colleague Felicity Walker.

2. February• Dr Sayeda Naher, pictured, joins

the AGITG as a Research Fellow.

3. March• The MONARCC clinical trial, led by

Dr Matthew Burge, pictured, for elderly patients with metastatic colorectal cancer opens for patient enrolment.

• The LIBERATE and DYNAMIC-III studies, both investigating ‘liquid biopsies’ as a method of detecting the presence of colorectal cancer, open for patient enrolment.

4. April• A team of nurses and a patient,

pictured, from Sir Charles Gairdner Hospital in Perth walk 12km and raise $11,000 for AGITG research.

• The Unicorn Foundation secures a $200,000 grant from Tour de Cure for the CONTROL NETs study.

• Dr Roland Main runs 21km in the Canberra Times Running Festival and raises funds for research in memory of his wife Deidre, who passed away from cholangiocarcinoma in 2016.

• Nisha Berthon-Jones joins the AGITG as Clinical Research Manager.

• The Scientific Advisory Committee set its research priorities for 2018.

• The SPAR clinical trials opens for enrolment of colorectal cancer patients.

5. May• Professor John Simes, pictured,

retires as a Director of AGITG and as Group Coordinator following 27 years of involvement.

• The AGITG Annual General Meeting is held to coincide with open meetings of the Upper and Lower GI Working Parties.

6. June• Dr Prunella Blinman, pictured,

presents a poster on the SCOT patient preferences sub-study at the American Society of Clinical Oncology Annual Meeting in Chicago.

• The results of the SCOT clinical trial are published in The Lancet Oncology. The trial found that three months of chemotherapy could be as effective as six months of chemotherapy in the treatment of advanced colorectal cancer.

• The SPAR trial receives a $1.2 million grant from the Health Research Council of New Zealand, giving the trial funding for full patient enrolment.

• The results of the ICECREAM clinical trial are published in Clinical Colorectal Cancer. Whilst the study observed less side effects when cetuximab was taken alone, there was significant benefit with the addition of irinotecan to cetuximab, with improved progression-free survival and an increased response rate in this patient population.

• Cancer Australia awards the AGITG and the NHMRC Clinical Trials Centre a three year infrastructure grant under the Support for Cancer Clinical Trials program.

7. July• The DYNAMIC-Rectal study, led

by Associate Professor Jeanne Tie, pictured, opens to patient participation. This study is analysing the presence of circulating tumour DNA (ctDNA) in the bloodstreams of patients with locally advanced rectal cancer treated with curative intent.

8. August• As part of the 'Silly Hat for Matt'

challenge, founded by Trine Simpson, pictured, a group of friends of the late Matt Simpson run the City to Surf and raise funds for research in his memory.

9. September• The MASTERPLAN trial, led by Dr

Andrew Oar, pictured, receives $1.5 million in funding from the Medical Research Future Fund. The trial is investigating the potential of stereotactic body radiotherapy in addition to modern chemotherapy in the treatment of pancreatic cancer.

• Jade Walker runs a 100km ultra-marathon and raises fun for research in honour of her friend who is undergoing treatment for GI cancer.

• The MODULATE study opens with first patient visit on Friday 21 September.

10. October• Vince Colagiuri, pictured with his

team, holds the Dominic Colagiuri Memorial Cup on 28 October to raise funds for research in memory of his brother, who passed away due to bowel cancer.

• The 20th AGITG Annual Scientific Meeting is held in Brisbane.

• Scientific Advisory Committee membership is refreshed and redefined as a smaller group.

11. November• OXTOX trial receives the AGITG

Innovation Fund Grant of $200,000. Pictured, Principal Investigator of the OXTOX trial, Dr Christina Teng, receives the award from AGITG Chair, Professor Tim Price.

• The CONTROL NETs trial finishes patient accrual.

• In the 2018 Gutsy Overland Challenge led by Professor Stephen Ackland, two teams take on Tasmania’s wilderness and the Overland track, raising over $120,000.

12. December• A team of 10 AGITG members

and supporters, pictured, cycle over 100km through the Snowy Mountains for the L’Etape Gutsy Challenge.

• CommNETs holds its first Clinical Trial Workshop in Hong Kong from 8-9 December.

• The second AGITG Joint Working Party Meeting of the year is held on 14 December.

• The second Scientific Advisory Committee meeting of the year is held on 17 December to identify grant and research priorities for 2019.

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127 research articles by AGITG, published in peer reviewed journals, changing

medical practice

57 clinical trialsimproving outcomes

for people with GI cancer

$55 million invested in AGITG

research

$27 years

of ground-breaking AGITG research

Since 1991, our key priority has been to undertake research that is centred on patient care and to improve medical practice in the treatment of gastro-intestinal (GI) cancer.

We put patients with gastro-intestinal cancer at the centre of our research, saving and improving lives by accelerating the pace of discoveries that lead to cures.

Our dedicated group of research and health professionals translate bold new ideas into life-saving clinical trials that help those patients as quickly as possible.

As a result, the Australasian Gastro-Intestinal Trials Group (AGITG) has been integral to worldwide changes in medical practice in a number of GI cancers, including gastric, pancreatic, colorectal, oesophageal and biliary tract cancers and gastrointestinal stromal tumours

(GIST). The Group has led trials in the treatment of stomach and rectal cancer and established surgical guidelines in Australia for pancreatic cancer.

We are a multi-disciplinary collaborative group of medical oncologists, radiation oncologists, surgeons, statisticians, data managers, allied health care professionals and consumers. Our research focuses on the ten GI cancers: oesophageal, stomach, liver, pancreas, gallbladder and biliary tract, large and small bowel, rectal and anal cancer. The GI Cancer Institute is the community division of the AGITG, working across Australia to raise funds and awareness of GI cancer and clinical trials.

What are clinical trials?Clinical trials contribute over $1.1bn annually to the Australian research and development (R&D) economy. More importantly, they give Australian patients access to potentially life-saving treatments.

Clinical trials are studies that explore the impact of new or existing approaches to health care. They generate evidence to inform best-practice ways of providing care or treatment to patients. The outcomes of clinical trials can provide evidence that leads to the adoption or continuation of effective treatment and care, or the cessation of ineffective interventions. Given the valuable insights that clinical trials offer, they are an important component of a ‘self-improving healthcare system’.

Treating GI cancers is complex and often involves a multimodal treatment strategy, that is, a combination of surgery, radiotherapy and chemotherapy. The investigator-initiated and collaborative clinical trials we conduct evaluate existing treatments to determine safety and effectiveness in new combinations and/or tumour types.

About Us

4,000+ patientsgiven access to new treatment regimens

on our trials

222 presentations based on AGITG trials

at global research conferences

The AGITG has conducted ground-breaking research in gastro-intestinal cancer for over 27 years. The AGITG is a network of dedicated health professionals who have contributed significant amounts of time and energy to improving the outcomes for people with GI cancer.

Professor Tim Price Chair AGITG

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Working with early career researchers to develop new concepts has immense value to the AGITG. This enables more new ideas to be developed and is an important way of ensuring that researchers gain the experience they need to conduct the best possible studies.

Dr Lorraine Chantrill Chair, Upper GI Working Party

Next Generation Researchers

The AGITG has conducted ground-breaking research for over 27 years, and the involvement of early career professionals ensures that this legacy will continue. We are proud to provide a platform for the brightest new GI cancer researchers to present their work. The collaboration between early career professionals and experienced researchers enriches the development of research and clinical trials. It is integral to ensuring that the AGITG continues to conduct innovative trials that change medical practice in GI cancer treatment.

Pictured (L-R): Early Career Researchers – Dr Howard Chan, Dr Monica Tang, Dr Sayeda Naher, Dr Elizabeth Connolly, Dr Christina Teng, Dr Sarah Maloney

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Item Research Priority

Thinking “outside the box” for appropriate new areas for research, including pharmacogenomics, pre-habilitation, and nutrition.

Foster innovation and develop novel approaches for:- Prevention, screening, diagnosis, treatment and control- Treatment modalities- Genomics- Investigating cancer biology.

Rare cancer possibilities, collaborative approach and investigation into potential future funding.

Investigate national and international funding and collaboration opportunities relevant for rare cancers, and develop a rare cancer model for AGITG.

Developing concepts in the rectal cancer space.

Current treatment favours early diagnosis, therefore developing concepts in rectal cancer is a priority to improve management.

Clinical trials in HCC and liver SBRT.Design clinical trials in Hepatocellular Carcinoma (HCC) including treatment strategies with Stereotactic Body Radiation Therapy (SBRT).

Rare cancer international collaborations for tumour streams and rare basket studies.

Engage international collaborators to develop basket and umbrella trials in rare cancers to enhance feasibility.

Mapping and summarising trial activity elsewhere, using this to inform future research opportunities.

Map national and international GI cancer clinical trial activity to ascertain current landscape and pro-actively contribute to idea generation.

Registry-based trials.

Develop pragmatic clinical trial paradigms to enhance generalizability to real-world patients, site participation and participant recruitment, reduce cost and research waste. Examples of such trial designs include:- Registry-based randomised trials- Adaptive platform trials- Observational studies.

Late-stage trials, particularly colorectal.Current treatment favours early diagnosis, therefore developing concepts in colorectal cancer is a priority to improve management.

Incorporation of patient-reported outcomes (PROs) into existing and new studies.

Integration of quality of life or other patient-reported outcomes (PROs) during concept development.

I think clinical trials are the best way to define and see evidence. Working with the AGITG has given me the opportunity to see how a clinical trial is developed, how it runs and what its pros and cons are. I think there is a lot of scope to increase prognosis and quality of life for people with GI cancers.

Dr Sayeda Naher Early Career Medical Oncologist AGITG Research Fellow

Nine Research Priorities to Accelerate Progress Against GI Cancer The AGITG Scientific Advisory Committee set the Group’s new research priorities in December 2018, defining areas of research that urgently need greater attention and have the potential to significantly improve the knowledge base for clinical decision-making and address vital unmet needs in GI cancer care.

The current list reflects AGITG’s Research Strategy — to undertake a strategic, multidisciplinary, program-based, collaborative clinical trials portfolio to

improve outcomes for patients with gastro-intestinal cancer. It focuses on pro-actively building the clinical trial portfolio, maximising recruitment and funding opportunities, fostering multidisciplinary national and international collaborations, maintaining and supporting a multidisciplinary membership base and maintaining efficient and cost-effective structures and processes for optimal use of resources.

Over time, AGITG’s Research Priorities will evolve with the cancer research landscape. They will be periodically updated to reflect advancing science and unmet clinical needs.

AGITG Research Priorities

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The AGITG plays a major role in clinical trial research on the global stage and has international collaboration links with Europe, Asia and North America.

92 Participating CentresClinical trials in recruitmentACTICCA-1, ASCOLT, DYNAMIC-III, DYNAMIC-Rectal, INTEGRATE II, LIBERATE, MODULATE, MONARCC, NABNEC, SPAR, TOPGEAR

Clinical trials in follow-upA La CaRT, ALT-GIST, CONTROL NETS, DOCTOR, InterAACT

26 Participating CentresClinical trials in recruitmentINTEGRATE II

Clinical trials in follow-up ALT-GIST

20 Participating CentresClinical trials in recruitmentINTEGRATE II, TOPGEAR

�� Participating CentresClinical trials in recruitmentTOP GEAR

Clinical trials in follow-up ALT-GIST

� Participating CentresClinical trials in recruitmentACTICCA-1, ASCOLT, DYNAMIC-III, DYNAMIC-Rectal, INTEGRATE II, SPAR, TOPGEAR

Clinical trials in follow-upALaCaRT

6 Participating CentresClinical trials in recruitmentINTEGRATE II

Canada

USAAsia

Australia NZ

Europe

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Asia New Zealand

Canada

Europe

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Our Global Presence

Pictured: Professor Daniel Chang, presenting at the AGITG Annual Scientific Meeting

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‘I joined the AGITG as a way of gaining access to the latest research in GI cancer treatment. Being part of the Group means being able to hear about new developments in research early and gain insight into the trial development process.

Dr Sarah Maloney Early Career Medical Oncologist

AGITG membership encompasses a wide range of medical specialists, scientists, nurses, allied health professionals and health consumers. We have over 1,100 members from Australia, New Zealand and around the world.

Our Members

20181167 Members

Membership

UP 10%

20171062 Members

A DB C E F G H

396

176

242

183

88

56

620

Members – Disciplines A. Medical OncologistsB. Trial Co-ordinators &

Data ManagersC. Allied Health ProfessionalsD. SurgeonsE. Radiation OncologistsF. ScientistsG. Health ConsumersH. Students/PhD Trainees

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Since 1991, we have made significant progress in our core business – the development and conduct of multi-disciplinary clinical trials to improve the lives of patients with GI cancer – by focussing on the patient at the centre of our research.

As health professionals and members of the AGITG, we focus on the patient every day in our clinical practices. When we sit across from our patient, discussing their symptoms, diagnosis, medical needs and treatment options, we want to ensure we are providing the best possible care. It is these conversations that spark an idea, beginning the development of a clinical trial and related research.

It is the patient that is the defining purpose for the existence of the AGITG and it is the patient who is the driving factor in the development of our Research Priorities, which are outlined on page 9.

The AGITG Scientific Advisory Committee has identified where more research is needed – on cancers with low survival rates, which have been given less attention to date as a result of underfunding and the sheer difficulty of diagnosis.

Recent clinical trials that have been developed to meet AGITG Research Priorities and address an area of great need include two trials for pancreatic cancer. The MASTERPLAN trial, funded in 2018 by the Medical Research Future Fund, aims to determine if the addition of stereotactic body radiotherapy (SBRT) to standard chemotherapy improves locoregional control for patients with high-risk operable, borderline resectable and locally advanced pancreas cancer. Also, funding is now being sought for a

pilot feasibility and discovery study of neoadjuvant FOLFIRINOX followed by immunotherapy for resectable adenocarcinoma of the pancreas. This study, led by Dr Lorraine Chantrill, was awarded the 2018 Best New Concept at the AGITG 20th Annual Scientific Meeting.

An important element of developing our clinical trials pipeline is our ongoing commitment to encourage and support the next generation of researchers. In 2018, the AGITG offered up to 15 grants for Fellows and Registrars to assist with their expenses to attend the AGITG Annual Scientific Meeting and to enable them to present in the Posters Session. Similarly, travel scholarships were made available to assist members from AGITG clinical trials sites who cannot access Institutional funds to attend the Annual Scientific Meeting.

There are so many dedicated individuals contributing to the success of our organisation. I was honoured to present the John Zalcberg OAM Award for Excellence in AGITG Clinical Trials Research to Professor John Simes. The Award recognises a member of the AGITG who has made significant and outstanding leadership contributions to AGITG clinical trials research over a sustained period. Professor Simes has had an exemplary career. He was a key member of the team of investigators that developed the first clinical trial conducted in Australia for GI cancer patients. Over his career, he has enabled over 80,000 people to access new and emerging treatments. His involvement in the AGITG commenced in 1991 when the AGITG was a network of interested Investigators that came together to develop and conduct the first trial in GI cancer, operating under the auspices of the National Health and Medical Research Centre (NHMRC) Clinical Trials Centre at the University

of Sydney. He was a founding member of the AGITG Board, and was the AGITG Group Coordinator for many years until handing over to Dr Katrin Sjoquist in May 2018. He has been a member of seven AGITG Trial Management Committees, including the practice-changing CO.17 trial in colorectal cancer.

There are many others who contribute to our work. Unfortunately it is not possible to list all the names of the many people in both the AGITG and the GI Cancer Institute community who have been instrumental in many ways to improving and extending the lives of patients with GI cancer, but to all of you, thank you. From the countless voluntary hours spent developing and conducting research, to trekking through Tasmania and cycling across the Alps in New South Wales, we must acknowledge the enormous effort made by innumerable people to address the needs of the patient at the centre of our research.

Professor Tim PriceMBBS DHthSc (Med) FRACP Chair

Chair's MessageI found out that I was eligible to participate in the TACTIC trial, which gave me extra time. My perspective is, I potentially don’t get to see my kids grow up, but with this trial I've had an additional six years and counting. I can’t describe how grateful I am for having more time with my family.

Raymond Yong Participant in the TACTIC trial

Pictured Left: Raymond Yong, participant in the TACTIC trial

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In 2018, a first-of-its-kind report from the Australian Institute of Health and Welfare (AIHW) provided a new understanding of all GI cancers and their impact in Australia.

Chief Executive Officer’s Report

The report, 'Colorectal and other digestive-tract cancers'* presented comprehensive data on GI cancers including: colorectal, pancreatic, stomach, liver, gallbladder and biliary tract, small intestine, oesophageal and anal cancer.

The report notes that GI cancer is a major cause of illness and death in Australia, accounting for about 2 in 10 (21%) of all cancers diagnosed and nearly 3 in 10 (28%) cancer deaths. The five-year survival rate for GI cancer has increased from 49% in 2017 to 51% in 2018.

It is encouraging to see the survival rate for GI cancers on the rise. This can be attributed to the efforts of dedicated medical professionals and generous donors and supporters for their continued persistence in confronting the difficult questions to improve

treatments for these devastating cancers. However, the number of people diagnosed with GI cancer has increased as has the rate of mortality. There is still much work needed to be done.

For over 27 years, members of the AGITG have recognised the need to focus on research and to increase funding opportunities for improved outcomes for patients with GI cancers. To this end, the key focus for the organisation in 2018 was the implementation of Year 1 objectives of the 2018–2022 Strategic Plan developed by the AGITG Board and Management to better position the organisation to accelerate the pace of discovery in GI cancer research. Details of our Research Priorities are outlined on page 9.

Notable outcomes over the course of 2018 that will have significant impact on our capacity to develop new research are:

• Establishment of AGITG Research

Priorities to guide our focus for new research.

• Development of an Idea Generation Workshop to be held in June 2019 to identify new ideas from all disciplines relating to gaps in current knowledge, for development in to future clinical trials.

• Development of a Translational Research Model to enable greater access to biological specimens via a web resource to foster collaboration with laboratory scientists.

Additional outcomes have been achieved in support of the strategic objectives including streamlining of scientific processes, a review of membership of our scientific committees across all disciplines and creation of a Communications Strategy to engage members.

Central to the AGITG Strategic Plan is investment in capacity-building projects including infrastructure

and proof-of-concept pilot research to support funding submissions for large-scale practice-changing research. The community arm of the AGITG, the GI Cancer Institute, has been charged with increasing charitable revenue to support grants awarded through the AGITG Innovation Fund.

The AIHW reported that colorectal cancer is the most commonly diagnosed GI cancer in Australia, estimated to make up almost 6 in 10 (59%) GI cancers diagnosed in 2018, while the number of people diagnosed increased to 17,004 from 16,682 in 2017. It was therefore timely that the 2018 AGITG Innovation Fund grant of $200,000 was awarded to Professor Janette Vardy and co-investigators for their pilot OXTOX study. The study will investigate whether an anti-inflammatory drug (ibudilast) decreases the severity of acute neuropathy and enables people with metastatic colorectal cancer to receive more chemotherapy

(oxaliplatin) before needing dose modifications for chemotherapy-induced neuropathy.

Of course, this research is not possible without considerable funding support. The 2018 Gutsy Challenge once again attracted a number of participants for two Gutsy Challenge treks, both held in Tasmania. One team was led by AGITG Director, Professor Stephen Ackland, and the second team led by GI Cancer Institute Fundraising Coordinator, Nicole Shore. In addition, a number of AGITG members rallied to the cause and took on a cycling Gutsy Challenge. Professor Nik Zeps, Professor Andrew Barbour and Dr Mustafa Khasraw led our inaugural L’Etape cycling team, affiliated with the Tour de France, taking on the hills and valleys of Mt Kosciusko.

Pictured (Top L-R): Rob Djundjek, Guy Tancock, Tony Ryan, Andrew Barbour, Richard Smith (front), Raymond Van Veenendaal (back), Nik Zeps, Mustafa Khasraw Not in photo: Tristan Yip

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Together, the three teams, plus the many additional inspiring Gutsy Challenges and community events, raised a total of $248,000 in support of the AGITG Innovation Fund. This amazing effort has contributed to a major milestone for the GI Cancer Institute. In 2018, we celebrated, with the support from our generous donors and AGITG members, securing over $1.1 million in charitable donations in support of GI cancer research. This was an extraordinary effort by each and every member of the GI cancer community who have responded to our requests for donations, participated in a Gutsy Challenge, donated to a friend undertaking a Gutsy Challenge, organised an event, left a gift in their Will or given in memory of a loved one.

The momentum is building in the community to find the answers. With 28,800 Australians receiving a diagnosis of GI cancer every year, as well as their families and

friends, the numbers are growing exponentially. It is this community of patients, families, survivors, carers, donors and supporters in collaboration with our medical professionals that will bring positive change in the treatment of GI cancer to further improve the lives of people with GI cancer.

Russell Conley FIML MFIA Chief Executive Officer

* AIHW ‘Colorectal and other digestive-tract cancers’ 2018

Pictured (Top L-R):1. Ruth Nissim, Lyn Hibbard, Ross Hinscliff,

John Mumford, Steve Ackland, Jan Mumford, Catherine Trevaskis, Andrew Kirsh

2. James Armstrong, Dylan Insana, Jess Insana and Autumn Tansey

3. Silly Hats for Matt -Trine Simpson

Momentum is building for GI cancer research in the community. We are witnessing an increase in awareness and greater engagement from the community and AGITG Members. This critical momentum will lead to improved outcomes for people with GI cancer.

Russell Conley Chief Executive Officer

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Group Coordinator’s Report

2018 was again a productive year for the AGITG clinical trials portfolio, with a number of notable achievements.

Since 1991, the AGITG has published 127 peer-reviewed journal articles and made 222 presentations of study findings at national and international conferences. 2018 was marked by significant progress on some major international trials, particularly in gastric cancer, as well as publications and the development of new trials.

The AGITG and the NHMRC Clinical Trials Centre were successful in once again obtaining Cancer Australia infrastructure funding in June 2018. This grant will support key staff positions for the development of new research protocols over the next 3 years (July 2018-June 2021).

During 2018, the MASTERPLAN clinical trial for high-risk and locally advanced pancreatic cancer patients was awarded funding from the Medical Research Future Fund. The trial seeks to determine whether stereotactic body radiotherapy (SBRT)

in addition to modern chemotherapy is superior to the current standard of chemotherapy alone in both the neoadjuvant and definitive setting. An important component of MASTERPLAN is to incorporate high quality tissue collection to facilitate future molecular and genetic research. MASTERPLAN is a major multi-disciplinary collaboration of Australia’s leading pancreatic clinicians and scientists, under AGITG leadership, in collaboration with the NHMRC Clinical Trials Centre and the TransTasman Radiation Oncology Group.

Three new studies in colorectal cancer commenced in 2018.

MODULATE aims to test whether it is possible to reverse the resistance of microsatellite stable (MSS) colorectal cancer to PD1 inhibition by combining the PD1 inhibitor nivolumab with other drugs designed to stimulate lymphocyte infiltration of tumours.

The SPAR study will evaluate the effect of simvastatin on efficacy and toxicity of pre-operative

chemoradiotherapy (pCRT) in rectal cancer patients, and on systemic and local inflammatory responses.

LIBERATE is a study to investigate liquid biopsies as a method of evaluating RAS mutation status in patients with advanced colorectal cancer. This involves determining the accuracy of results of liquid biopsies, compared to genetic testing of cancer tissue. Different methods of testing liquid biopsies will be studied and compared. The study will also assess whether the ability of liquid biopsies to detect cancer gene mutations is different at different time points.

In collaboration with the Walter & Eliza Hall Institute of Medical Research, two new studies focusing on circulating tumour DNA, DYNAMIC-III and DYNAMIC-Rectal, commenced recruitment. These studies will determine whether a chemotherapy decision based on the presence or absence of circulating tumour DNA after surgery will be more effective than standard of care treatment.

We look forward to the commencement of three new trials over the coming year.

OXTOX, recipient of the 2018 AGITG Innovation Fund grant, aims to determine whether ibudilast has the potential to decrease the severity of acute neurotoxicity and chemotherapy-induced peripheral neuropathy in patients with metastatic colorectal cancer receiving oxaliplatin.

A new trial for rectal cancer, RENO, will study the ‘Watch and Wait’ strategy in patients who have developed a Clinical Complete Response with concurrent chemo-radiotherapy.

Joining the pancreatic cancer portfolio, the DYNAMIC-Pancreas trial will involve an analysis of circulating tumour DNA to inform adjuvant chemotherapy.

During 2018, much work was undertaken in preparing new concepts and grant applications thanks to the diligence of people

within the AGITG and the NHMRC Clinical Trials Centre with input from the AGITG Upper and Lower GI Working Parties.

A great deal of work by the dedicated operations team at the NHMRC Clinical Trials Centre has occurred to close out some of the older AGITG trials: TACTIC, ATTACHE, QUASAR2, REGISTER, LAP07 and ADVANCED GIST have all been completely closed and archived during 2018. Work will continue in coming months to finalise an additional seven trials.

There were nine peer-reviewed manuscripts published in 2018 and nine presentations at international conferences including the European Society for Medical Oncology Congress, the American Society of Clinical Oncology Annual Meeting, and the American Society of Clinical Oncology Gastro-Intestinal Cancers Symposium.

The collaboration of many people on a global basis continues to underpin

the efforts of our clinical trials research program. The hard work of clinical investigators, research coordinators and staff at each site, at the AGITG, the NHMRC Clinical Trials Centre, and all the AGITG committee members, have contributed significantly to the successful outcomes of this research. We are indebted to the patients and their carers for their support and the vital services they bring to these trials.

Professor John Simes MD MBBS BSc SM FRACP Group Coordinator until May 2018

Dr Katrin SjoquistBSc(Med) MBBS MClinT(R) FRACP Group Coordinator from May 2018

Pictured (Top L-R): Professor John Simes, Professor Tim Price

The 57 clinical trials conducted by the AGITG since the group was first formed in 1991 have involved over 4,000 patients treated at 90 sites in Australia, 8 sites in New Zealand and over 90 sites located across Asia, Europe and North America.

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The AGITG Consumer Advisory Panel (CAP) comprises of GI cancer survivors, patients and carers.

CAP members come from across Australia. Upper and lower GI cancers are represented and members have both patient and carer experiences.

CAP key activities include the review of new trial concepts, identification of gaps in research, assistance to ease the understanding of trial patient information and consent forms, and advice on patient recruitment strategies.

Consumer input is an important element in AGITG clinical trials and CAP members are invited to participate in the Trial Management Committees of AGITG clinical trials. In 2018, the CAP reviewed lay summaries for the MODULATE and LIBERATE grant applications and patient information consent forms for the MASTERPLAN, RENO and MODULATE trials.

2018 saw the continued involvement of CAP members in funding submissions to the NHMRC. CAP members were involved in both the NAP CAPABIL and MASTERPLAN applications for funding. MASTERPLAN successfully secured funding through the Medical Research Future Fund. CAP members James Armstrong and Jan Mumford contributed to the submission and have been included as Associate Investigators (AI) for this project.

The Chair and Deputy Chair of the CAP both participate in the development of trials through membership on the Upper and Lower GI Working Parties. Other activities in 2018 included contributions to the selection of the AGITG Outstanding Site Award, Innovation Fund grant and Kristen Anderson Award for the 2018 Annual Scientific Meeting (ASM).

The CAP also supports the GI Cancer Institute with community outreach initiatives by participating

as speakers, attending the Living Room Series to update the community and supporting fundraising through programs such as the Gutsy Challenge. In November, CAP member Gill Worden and I participated in the Gutsy Overland Challenge in Tasmania. We trekked over 60km through the wilderness, a thrilling and challenging experience to raise awareness and funds for GI Cancer research.

Jan Mumford Chair Consumer Advisory Panel

Pictured (L-R) Top Row: Ms Christine Bishop, Mr James Armstrong, Mr Brian Wall, Mr Grant Baker, Ms Autumn Tansey, Mr Jeff Cuff. Bottom Row: Ms Gillian Worden, Mr Robin Mitchell, Ms Jan Mumford, Ms Julie Marker

Gill’s StoryWhen Gill Worden saw that the GI Cancer Institute was looking for people to join its Consumer Advisory Panel in 2017, she almost didn’t send in an application.

“I was very unsure about whether I was ready to do it or not,” she says. Her husband had passed away from stomach cancer in 2013, and it was hard to know if she was prepared to take on a role on the CAP. Despite her reservations, she also felt that it was important to potentially make a difference for other people affected by cancer.

“I felt like I had something to contribute,” she says. “Giving back to the people who were doing the research, doing the hard yards for people like my husband. I felt like potentially if I could make a difference for somebody else then it would be worth it.”

In 2018, Gill took on the Gutsy Overland Challenge, trekking over 60km over seven days through the Tasmanian wilderness. Through this extraordinary achievement, she raised over $8,000 for research and clinical trials.

“The more people who participate in clinical trials, the better the research,” says Gill. “The better the research, the better the outcomes for people in the future. I want to facilitate that process of people participating in clinical trials which is so important to improving research.”

As a volunteer group, the Consumer Advisory Panel provides advice to the AGITG on general research directions and priorities from a health consumer perspective, identifying unmet needs in the community.

Consumer Advisory Panel Report

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��.4%�-year survival rate

Help us lift the survivalrate of

GI cancer

GIcancer

Breastcancer

Prostatecancer

51%

95%91%

28,880 Australiansare diagnosed every year

with GI cancer

38 Australians die every day of the year

as a result of GI cancer

38

1 person dies every 37 minutes

from GI cancer

OESOPHAGUS

��%�-year survival rate

GALL BLADDER & BILE DUCT

��.7%�-year survival rate

SMALL BOWEL

�5.8%�-year survival rate

Funding Gastro-Intestinal Cancer ResearchMore funding = better survival rates

There is still much work needed and there are many more questions to be answered to improve survival rates and treatment for GI cancer. In 2018, in Australia, GI cancer has a diagnosis rate which is 58% higher than breast cancer and 63% higher than prostate cancer. Both breast and prostate cancer have witnessed steady progress in treatment and improved survival. These two cancer types now have five-year survival rates greater than 90% because of significant research funding.

Research funding for cancers of the colon and rectum, pancreas, oesophagus and stomach is low compared with the burden that these diseases have on the Australian population. Cancer Australia has recommended prioritising research funding investment for these cancers to deliver improvements in cancer care and outcomes.*

* Cancer Research in Australia 2016 to 2018 Opportunities for strategic research investment

Improving survival rates for GI Cancer

24 2524 25

My PhD studies have contributed to the development of the phase two OXTOX trial which is now in activation, thanks to the AGITG Innovation fund. This research will lead to important knowledge about neuropathy for colorectal cancer patients. I am very grateful to the donors who have funded the study, and to have the support of the AGITG for this research into prevention of oxaliplatin neurotoxicity.

Dr Christina Teng Early Career Medical Oncologist

Pancreas

From

3%1982 - 1987

Up to

8.7%2018

Oesophagus

From

9.8%1982 - 1987

Up to

21%2018

Liver

From

7%1988 - 1993

Up to

18.1%2018

Gallbladder & Bile Duct

From

10%1982 - 1987

Up to

19.7%2018

Colorectal*

From

48%1982 - 1987

Up to

69%2018

Stomach

From

17%1982 - 1987

Up to

29.5%2018

Clinical TrialsAGITG clinical trials have contributed significantly to the improvement of outcomes for people with GI cancer. The estimated five-year survival rates for all GI cancers have improved, showing the positive outcomes of research.

Improved five-year survival rates* Colorectal cancer includes cancers of the colon and rectum.

Historical data for small bowel and anal cancer is not available.

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Oesophageal cancer in Australia continues to grow at an alarming rate. In 2011, there were 1,396 new diagnoses, and in 2018, there were 1,685 diagnoses and it claimed 1,447 lives. The five-year survival rate is only 21%.

Trials open to recruitmentINTEGRATE II There are currently few effective treatment options for patients with Advanced Gastro-Oesophageal Cancer (AGOC) that has returned after surgery, or where it is metastatic at diagnosis. Chemotherapy can be effective at first, but once the cancer has become resistant to it, the options for treatment are limited. For those who do receive additional courses of chemotherapy, their cancer will eventually become resistant (or ‘refractory’) to these drugs. In these situations, there are currently no accepted treatment options that have been shown to be both effective against the cancer and tolerable for patients. Better treatment options are urgently needed.

The INTEGRATE II trial is testing regorafenib (BAY 73-4506), a 'multi-targeted therapy' which targets a number of different signals in the cancer cell that cause it to grow and produce blood vessels. In other cancers, such as colon cancer and GIST, regorafenib has been proven to be of benefit when other drugs have ceased to work. The earlier AGITG Phase II trial, INTEGRATE, demonstrated efficacy with the use of regorafenib in AGOC, and could potentially become a new standard of care after other therapeutic agents have stopped working. INTEGRATE II is being undertaken to confirm the findings of the Phase II trial in a larger population. If the study is positive it will provide evidence

for regorafenib as a new standard of care after other treatments no longer benefit patients with stomach cancer, also known as gastric cancer.

Following the promising results from the INTEGRATE study, INTEGRATE II, an AGITG-led Phase III clinical trial in gastro-oesophageal cancer, is open to patient participation in Australia, New Zealand, Korea, Canada, and Taiwan. The first patient on the study was recruited in October 2016 at Townsville Hospital, QLD. Since that time, 27 sites have opened throughout Australia and New Zealand, which have recruited 42 patients, 15 sites in Korea, recruiting 40 patients, seven sites in Canada, recruiting 11 patients, and four sites in Taiwan, recruiting 11 patients. Six sites in the US have confirmed participation, while five sites expected to open in Japan in the first quarter of 2019.

Trials in follow-upDOCTORThis study broke new ground in pre-operative therapy for oesophageal cancer. It was the first to focus on changing the therapy for metabolic non-responders to pre-operative therapy to try to improve response and, potentially, survival. It was also innovative in other ways, such as assessing whether changing therapy can salvage a response. It provided valuable data regarding the potential to individualise therapy related to the tumour characteristics – so-called ‘tailored therapy’. Surgery forms the mainstay of curative treatment but survival remains poor. Pre-operative chemotherapy, with or without concurrent radiotherapy, has resulted in modest improvements in outcome. Increasing the proportion of responders to pre-operative therapy remains one of the major challenges facing patients with localised oesophageal cancer. Recruitment of patients ended on 31 December 2015.

The primary analysis was presented at the 2016 Congress of the European Society of Medical Oncology (ESMO). Docetaxel added to chemotherapy and particularly with radiotherapy can induce high rates of histological responses in non-metabolic responder patients. Therefore, tailoring multimodal therapy based on individual PET response is safe and feasible in oesophageal cancer, although the impact on survival required longer follow-up. In 2018 the trial was selected for a poster presentation at ESMO, providing updates on secondary endpoints including progression free survival and recurrence after 3 years.

The main conclusions were that: • Early metabolic response is

associated with a favourable progression free survival (PFS) and a low rate of local recurrence (LR)

• The addition of docetaxel in the metabolic non-responders group may augment histological response rate, but PFS and LR outcomes remained inferior.

• Combination therapy with docetaxel, cisplatin, 5FU and radiotherapy (DCFRT) produced the highest histological response rate (RR) and PFS/LR outcomes, matching the early metabolic responders.

• Early PET assessment for metabolic response has the potential to tailor therapy for patients not showing an early metabolic response to chemotherapy.

Further follow-up is ongoing.

Clinical Trials: Oesophageal CancerI find GI cancers interesting because they encompass a range of malignancies, with different biologies and treatments. Seeing patients with different GI cancers in the clinic is also interesting and adds variety to my role. As a Research Fellow I have developed skills and experience in designing and implementing clinical trials, and been able to use these skills to contribute to the important work of the AGITG.

Dr Monica Tang Early Career Medical Oncologist AGITG Research Fellow

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AGITG membership has given me access to information on the newest treatments for GI cancers, which means that I can give my patients the best possible treatment for their survival and quality of life.

Dr Elizabeth Connolly Early Career Medical Oncologist

Although stomach cancer is on the decline in Australia, it still affects a significant number of people. In 2011, 2,093 Australians were diagnosed with the disease and 1,143 people died in 2012. In 2018, the incidence of stomach cancer increased to 2,332; however, fewer people, 1,078 died in the same year.Trials open to recruitmentTOPGEARFor patients with stomach cancer, surgery may cure those with localised cancer, but most patients present with more advanced cancer. When treated with surgery, it will recur in 70% of patients.

Thus, surgery alone is not an adequate treatment. There are currently two ‘standard’ methods used worldwide to treat patients whose stomach cancer is more advanced – either treatment with chemotherapy before and after surgery, or a combination of radiation plus chemotherapy following surgery.

We believe that combining these two approaches will provide even greater benefit, especially if the combination of radiation plus chemotherapy is given prior to surgery.

This randomised controlled trial will build on previous research conducted and compare chemotherapy given before and after surgery, with or without adding concurrent chemotherapy and radiotherapy. The trial is being led by Australian investigators and includes participation by groups in Australia, Canada and Europe.

TOPGEAR is currently in phase III with 450 patients enrolled as of 31 December 2018 out of a target accrual of 620. A formal analysis took place in 2018, which included testing for efficacy (progression free survival) and futility.

GIST Trials in follow-upALT-GIST Gastro-intestinal stromal tumours (GIST) are rare cancers that can develop in different locations throughout the gastro-intestinal tract. When they have spread to other places (metastasised) or are not able to be surgically removed, they are not curable with any current treatment.

Medications have been developed that improve survival in patients with metastatic GIST. They work by blocking the signals that make these cells grow and spread. One of two drugs available on the Pharmaceutical Benefits Scheme in Australia, imatinib is used as the initial treatment for incurable GIST. Although many people with metastatic disease respond to imatinib initially, in almost all cases the cancer eventually becomes resistant to this drug and starts to grow. Until recently, a search for active new medicines in this setting had failed, but since then, regorafenib was shown to significantly delay progression in this setting. Regorafenib works in a similar way to imatinib although it targets a number of additional enzymes in tumour cells. This may explain its activity when imatinib is no longer active.

Recruitment of this trial closed in December 2017. There are 37 sites participating across Australia, Asia, Europe and Scandinavia with 78 patients recruited. An analysis of initial results was completed at the end of 2018 and the results are currently being interpreted. The trial follow-up will be ongoing until June 2019.

NETs Trials in recruitment NABNECThe aim of the study is to assess if a carboplatin and nab-paclitaxel chemotherapy combination is an

effective and tolerable treatment for advanced Neuroendocrine Carcinomas (NECs). The trial will also look at outcomes of survival, monitor the side effects of treatment, identify useful markers of prognosis and response, and increase our understanding of the biology of NECs.

NABNEC was funded by an NHMRC Project Grant from 2016-2020 and ethics approval was obtained in March 2016. Seventeen sites have been selected. Additional payment per patient and supply of nab-paclitaxel was provided by Specialised Therapeutics Australia and executed in August 2016.

Since the study opened in 2016, 26 patients have been recruited to the trial. A poster was presented at the European Society for Medical Oncology (ESMO) meeting in 2017 and has been accepted for a poster presentation at the American Society for Clinical Oncology GI (ASCO-GI) meeting in 2018.

Trials in follow-upCONTROL NETsThe aim of the study is to assess whether the combination of radiopeptide and chemotherapy is more effective than either radiopeptide or chemotherapy alone in mid-gut and pancreatic NETs. If the combination treatment demonstrates a more positive effect, this could then be further investigated in a larger phase III randomised trial, the results of which would guide best practice.

The study closed to recruitment in November 2018 after reaching its final target of 75 patients. Although CONTROL NETs was unsuccessful in receiving a grant from the NHMRC in 2017, the study has been supported by additional funds from the Unicorn Foundation. In 2018 a grant was secured by the Unicorn Foundation from Tour de Cure to support the trial.

Clinical Trials: Stomach Cancer, GIST & NETs

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Pancreatic cancer is amongst the most lethal of all adult cancers and growing – 3,364 people were diagnosed with pancreatic cancer in 2018 and an estimated 3,006 people died from it in Australia in 2018. The five-year survival rate is just 8.7%. There have been no major improvements in outcomes over the last 30 years.

Trials in activationDYNAMIC-Pancreas DYNAMIC-Pancreas is investigating whether circulating tumour DNA (ctDNA) analysis can inform adjuvant chemotherapy in early stage pancreatic cancer.

In the majority of cases, long-term survival can only be achieved with surgical removal of localised disease but despite surgery with ‘curative intent’, 80-85% of patients relapse. Clinical trials have shown that chemotherapy after surgery may provide some benefit. The use of a single drug treatment with gemcitabine or fluoropyrimidine was accepted as standard of care. However, results from a recent trial in patients with advanced pancreatic cancer demonstrated a significant improvement in overall survival when they were treated with a combination therapy (that is, gemcitabine plus capecitabine versus gemcitabine alone). This may translate into greater benefits for patients with localised pancreatic cancer. However, it remains difficult to adequately measure risk and treatment effectiveness for all patients.

The aim of the DYNAMIC-Pancreas study is to demonstrate that a ctDNA-informed approach to chemotherapy, following surgery for localised pancreatic cancer, could lead to a reduction in the proportion of patients with detectable ctDNA after completion of treatment compared

to standard of care. Recruitment for patients will open in 2019.

MASTERPLANThis study aims to determine if adding stereotactic body radiotherapy (SBRT) to modern chemotherapy (mFOLFIRINOX or gemcitabine with nab-paclitaxel) for patients with high-risk or unresectable (locally advanced) pancreatic cancer improves cancer control rates in and around the pancreas. A target of 120 patients will be recruited to determine if the cancer control rate (termed locoregional control) is considered superior with SBRT, compared to without.

Stereotactic body radiotherapy is the delivery of high doses of radiation to a tumour. Due to advances in technology, such as better imaging and better methods of radiation delivery, this treatment is now done for many tumour sites (lung, prostate, brain). In the setting of pancreatic cancer, SBRT has the advantage of being able to deliver radiation over a shorter period, two weeks rather than five weeks.

MASTERPLAN received grant funding from the Medical Research Future Fund in late 2018. The trial will open to recruitment in 2019.

Cancer of the gallbladder and bile ducts is rare, with 931 people diagnosed in 2018 and 262 deaths in 2018. The five-year survival rate is only 19.7%.

Trial in recruitmentACTICCA-1Cholangiocarcinoma is a type of cancer that develops in the bile ducts. Bile ducts are tubes that drain bile, a fluid produced in the liver, into the gut to help with the digestion of food. This type of cancer is rare, with only a few hundred cases in Australia every year. It occurs more often as people get older. There are still many unanswered questions about the best

way to treat this cancer. If the cancer is only in the bile ducts, and has not spread to other parts of the body, the best treatment is to remove all the cancer with surgery. Unfortunately, even though surgery is sometimes possible, the cancer can come back in many people. For some other types of cancer, giving extra treatment with chemotherapy after surgery has been useful. However, there is no definitive trial evidence at the moment to show if this is true for cholangiocarcinoma. There is a need for a comparison study to help improve the survival for people with this cancer.

This trial will help us to know if giving a chemotherapy combination of cisplatin and gemcitabine after surgery is better than standard of care treatment after surgery for cholangiocarcinoma in non-metastatic patients. It will monitor people to see how often their cancer comes back, and see if this happens less often when the combination chemotherapy is used. It will also monitor the side effects from the treatment, quality of life and complications from surgery, amongst other things.

This trial initially opened to recruitment in Australia in July 2016 and initially compared the combination of chemotherapy with cisplatin and gemcitabine after surgery to observation only after surgery. In 2017, results from another clinical trial demonstrated that treating patients with capecitabine delays recurrence of their cancer. This chemotherapy treatment has been adopted as standard of care since then. Therefore, the ACTICCA-1 clinical trial was temporarily stopped and the aim was adjusted to compare the ACTICCA-1 study treatment to the new standard of care treatment with capecitabine. The trial reopened to recruitment in November 2017.

As of 31 December 2018, 12 Australian sites have opened and 5 patients have been recruited.

Clinical Trials: Pancreatic, Gallbladder & Biliary Tract CancerThrough the AGITG I have been able to connect with other cancer specialists, and had the opportunity to learn and collaborate with researchers passionate about improving outcomes for patients.

Dr Howard Chan Early Career Medical Oncologist AGITG Research Fellow

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Colorectal cancer is cancer of the colon or rectum. It is also called bowel cancer and is the most common type of GI cancer. Australia has one of the highest rates of colorectal cancer in the world. In 2018, 17,004 people were diagnosed with colorectal cancer and 4,129 died in Australia. The five-year survival rate is now 69.4%.

Trials in activationRENORENO is a prospective study of ‘Watch and Wait’ strategy in patients with rectal cancer who have developed a clinical complete response with concurrent chemoradiotherapy.

Rectal cancer is a common malignancy and comprises a third of the cases of colorectal cancer. Currently, a combination of chemotherapy plus radiotherapy followed by surgical resection of the rectum is the standard management of locally advanced rectal cancer. Approximately 20% of patients develop a pathological complete response to chemoradiation. In these patients, surgery may not be necessary. There are retrospective studies showing the safety of a 'Watch and Wait' strategy instead of surgery in patients who do not have any signs of disease after completing chemoradiation. This approach may save the patient from surgical risks and long-term morbidity.

With this study, the aim will be to assess the safety of the watch and wait approach in this population and prove the feasibility of a structured follow-up program. The study will also assess novel biomarkers, patient reported outcome measures and health economics, none of which have been studied in this population.

As of 31 December 2018, this trial was in activation and set to open in 2019.

Trials in recruitment DYNAMIC-IIIThe aim of this study is to compare treatment informed by circulating tumour DNA results to standard care in patients with stage III colon cancer.

Currently, the standard treatment for stage III colon cancer is surgical removal of the tumour followed by 3-6 months of chemotherapy. Chemotherapy is given as a combination treatment made up of 3 drugs including oxaliplatin or as a single drug treatment with fluoropyrimidine. Although studies have shown that chemotherapy reduces the risk of the cancer returning, not all patients benefit from treatment. For some, the cancer is cured by surgery alone, and others will experience cancer relapse even with treatment. It is difficult to adequately measure risk and treatment effectiveness for all patients.

The use of a biomarker that can better define the risk of the bowel cancer returning could make a major impact on treatment decisions for patients with stage III colon cancer. Circulating tumour DNA (ctDNA) may act as one such biomarker. For some people, cancer DNA can be found circulating in the bloodstream after the surgery to remove their bowel cancer, which provides evidence that some cancer cells have escaped and travelled to other parts of the body. A previous study in patients with bowel cancer has shown that people with ctDNA detected in their blood after surgery have a very high chance of the cancer coming back compared to those with no ctDNA. Therefore, this study is trying to see if a chemotherapy decision based on the presence or absence of ctDNA after surgery will be more effective at determining the optimal type and

duration of chemotherapy treatment that a patient will need after surgery.

As of 31 December 2018, 20 sites had been activated and 126 patients had been recruited out of a target of 1000.

DYNAMIC-RectalColorectal cancer remains a major health burden in Western countries and is rapidly increasing in incidence in other countries where Western lifestyles are being adopted. Approximately 30% of colorectal cancers arise within the rectum, where pre-operative chemo-radiation and then surgery is standard for patients with locally advanced rectal cancer (LARC). While multiple advances have been made in managing rectal cancer, patient selection for adjuvant chemotherapy after surgery, and agent choice remain major clinical dilemmas.

Initial studies have demonstrated the potential utility of ctDNA as a marker of recurrence risk. The end goal for LARC patients is to integrate ctDNA analysis into routine clinical practice to guide treatment decisions and most importantly benefit patients. However, this will demand multiple studies, each building upon previous clinical trials toward the ultimate aim of improving patient survival. This initial study has been designed to determine whether a ctDNA-based approach to adjuvant therapy will lead to substantially less patients receiving adjuvant therapy.

DYNAMIC-Rectal opened to recruitment in July 2018. As of 31 December 2018, 14 sites had been activated and 24 patients had been recruited out of a target of 408.

LIBERATELIBERATE is a study evaluating liquid biopsies to profile metastatic colorectal cancer. The purpose of this study is to investigate liquid biopsies as a method of evaluating RAS mutation status in patients with advanced colorectal cancer. This

involves determining the accuracy of results of liquid biopsies, compared to genetic testing of cancer tissue. Different methods of testing liquid biopsies will be studied and compared. The study will also assess whether the ability of liquid biopsies to detect cancer gene mutations is different at different time points.

This study will compare the results of liquid biopsies with results from traditional genetic testing of cancer tissue, in order to validate liquid biopsies as an acceptable method of evaluating RAS mutation status.

Recruitment for patients opened in 2018. As of 31 December 2018, 13 sites have been activated and 50 patients have been recruited out of a target of 100.

MODULATEColorectal cancer is the most commonly diagnosed cancer in the Australian population. Surgery, with or without chemotherapy and radiotherapy, can be used to cure colorectal cancer that is diagnosed early. However, cases of advanced colorectal cancer where it has spread to other organs usually cannot be cured. Advanced colorectal cancer is treated with chemotherapy and other drugs, known as targeted therapies. This can control advanced colorectal cancer for a limited time, but inevitably these cancers will evolve to become resistant to all the standard treatments available. By the time cancers progress to this stage, survival is poor and patients are increasingly symptomatic. Additional therapies are therefore needed to further extend survival of patients with advanced colorectal cancer.

This study aims to test whether it is possible to reverse the resistance of MSS colorectal cancer to PD1 inhibition by combining the PD1 inhibitor nivolumab with other drugs designed to stimulate lymphocyte infiltration of tumours. Two approaches will be tested: an

inhibitor of the signalling protein STAT3, and a vascular disrupting agent which blocks the blood supply of cancers. Pre-clinical laboratory studies suggest that targeting STAT3 or using vascular disrupting agents will improve lymphocyte infiltration into cancers, but this has not been proven in human studies.

MODULATE opened in September 2018. As of 31 December 2018, 11 sites had been activated and 45 patients had been recruited out of a target of 90.

MONARCCThe aim of this study is to investigate the activity of treatment with the anti-EGFR therapy panitumumab alone and panitumumab combined with 5-fluorouracil chemotherapy, in a molecularly selected, elderly patient population with metastatic colorectal cancer.

Metastatic colorectal cancer is a disease of the elderly. Anti-EGFR antibodies have not been well studied in an elderly patient population unsuited to combination chemotherapy. The median age in trials involving these agents is 60-65 years. As a result, there is an opportunity to investigate the activity of anti-EGFR monotherapy, or combined with “light” chemotherapy in a molecularly selected, hitherto under-investigated but prevalent patient population.

Recruitment for patients opened in 2018. As of 31 December 2018, 15 sites have been opened and four patients have been recruited out of a target of 80.

SPARThis randomised phase II trial aims to evaluate the effect of simvastatin on efficacy and toxicity of pre-operative chemoradiotherapy in rectal cancer patients, and on systemic and local inflammatory responses. Rectal cancer is often treated by chemotherapy and radiation before

surgery, but if the cancer responds poorly to this treatment many patients relapse. Retrospective studies show better cancer responses and fewer side effects in patients taking a statin drug (for cholesterol) during radiation therapy. This study aims to recruit 222 patients from hospitals in Australia and New Zealand to test if taking a statin for 3 months (during combined chemotherapy and radiation then for another 6 weeks) improves the rate of good tumour response and reduces side effects of this treatment.

Recruitment for patients opened in April 2018. At end of 2018, 5 sites in Australia and 1 site in New Zealand were open to recruitment and 6 patients have been recruited.

Anal Cancer Trials in follow-upInterAACTThe main purpose of this international, multicentre trial is to establish which chemotherapy regimen is more effective for inoperable advanced or metastatic anal cancer. By comparing two well-known and widely used combination chemotherapies, researchers aim to demonstrate which one is more effective and less toxic for patients with this disease. The results of this study are likely to establish the standard of care for patients with inoperable anal cancer. This study also aims to acquire important information on the biology of anal cancer by incorporating translational research as part of its overall research aim.

The first site was open to recruitment in March 2016. Since then an additional four sites opened and three patients in Australia were recruited.

The trial closed to recruitment in 2017.

Clinical Trials: Colorectal & Anal Cancer

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Roland’s StoryOn 14 April 2018, Roland Main ran 21km as part of the Canberra Times Australian Running Festival to raise funds for GI cancer research. Roland lives and works as a psychiatrist in Perth but travelled to Canberra, where his son lives, to complete the half-marathon.

“I enjoy the Canberra run – I think it’s a lovely course,” he says. It was Roland’s second year running the half-marathon. Roland was supported in his efforts by his daughter, who also travelled to Canberra for the festival, and his son, who ran the marathon with him.

His motivation for supporting the GI Cancer Institute was a personal one – in 2016, his wife, Deidre, passed away from cholangiocarcinoma, a rare form of biliary tract tumour. He hopes that his efforts will contribute to

improving the treatment options for other people affected by cholangiocarcinoma.

“There’s nothing like personal experience to bring you closer to a charity,” he says.

“Deidre’s treatment included all sorts of options including some pretty cutting edge stuff. We started to see some of the first forms of immunotherapies and the like for those sorts of tumours.”

“You don’t get to that point without some research being done.”

Many AGITG trial patients donate tissue and blood samples collected for research. These samples are used in translational research studies to seek biomarkers, biological flags that may help to select patients who are most likely to benefit from a treatment or spare particular patients from treatment toxicities.

Thirty-seven AGITG trials currently collect or have collected tissue and blood from patients. Over 80% of these trials have confirmed translational research studies using these samples. Work is progressing with our local and international research collaborators on many of these studies.

The science of these translational research proposals are reviewed by the trial management committees, the Upper and Lower GI Working Parties and the Scientific Advisory Committee.

The joint AGITG and the Canadian Clinical Trials Group (CCTG) Correlative Research Committee also review translational research proposals relating to three colorectal cancer trials (CO.17, CO.20 and CO.23). There are currently 19 translational research studies underway using biospecimens from these trials.

2018 highlights include • ASCOLT translational research study

was awarded an NHMRC project grant to study to seek a signature of genes and molecular markers to help predict which colorectal cancer patients will benefit from aspirin use after surgery.

• Danielle Ferraro, recipient of the inaugural Kristian Anderson Award and former clinical fellow of the NHMRC Clinical Trials Centre and AGITG, travelled to Toronto to continue our collaboration with CCTG on tissue biomarker studies of colorectal cancer trials (CO.17 and CO.20).

• Our trials are using a range of technologies to analyse patient samples:

- Proteomics is being used to analyse large numbers of blood proteins in 2 trials: INTEGRATE (gastro-oesophageal cancer) and GAP (pancreas cancer).

- A platform allowing large-scale analysis of gene expression (RNA from tissue samples) is being used in the GAP and CO.23 trials.

- Circulating tumour cells that have sloughed off from the primary solid tumour are being isolated from patient blood for further study in the NABNEC trial (neuroendocrine tumours).

Tissue and blood samples collected from AGITG trial patients are an important part of our research. It is exciting to see the number of trials growing, meaning that the scope to develop new approaches to treatment is broader.

Dr Sonia Yip, PhD Translational Research Lead Senior Research Fellow

Translational Research

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As a GI cancer survivor, it is great to see so many new research concepts being developed, and the fresh faces each year who step forward to contribute to finding better treatments. Survival rates are rising as more, and more GI cancer specialists are dedicating their time and expertise to research.

Mr Dan Kent AGITG Director

Journal publications and conference presentations provide clinicians and patients with the most up-to-date treatments results. In 2018, the AGITG published clinical trial results in leading international medical journals. The seven publications and eight presentations included trials in advanced gastric cancer, gastro-intestinal stromal tumours (GIST) and locally advanced rectal and pancreatic cancer.

Publications A La CaRTStevenson A, Solomon M, Brown C, Lumley J, Hewett P, Clouston A, Gebski V, Wilson K, Hague W, Simes J. Disease-free Survival and Local Recurrence After Laparoscopic-assisted Resection or Open Resection for Rectal Cancer: The Australasian Laparoscopic Cancer of the Rectum Randomised Clinica Trial. (Ann Surg 2019;269:596–602)

ASCOLTSegelov E, Siever O, Chia JWK, Williams DS. COX2 and HLA immunohistochemical (IHC) staining in colorectal tumour samples from patients participating in the ASCOLT clinical trial of adjuvant aspirin therapy. J Clin Oncol. 2018 Feb; 36 (4_suppl), 695

CO.23Jonker DJ, Nott L, Yoshino T, Gill S, Shapiro J, Ohtsu A, Zalcberg J, Vickers MM, Wei AC, Gao Y, Tebbutt NC, Markman B, Price T, Esaki T, Koski S, Hitron M, Li W, Li Y, Magoski N M, Li CJ, Simes J, Tu D, O'Callaghan CJ. Napabucasin versus placebo in refractory advanced colorectal cancer: a randomised phase 3 trial. Lancet Gastroenterol Hepatol, 2018 Apr; 3(4):263-270. doi: 10.1016/S2468-1253(18)30009-8. Epub 2018 Feb 1.

ICECREAMShapiro JD, Thavaneswaran S, Underhill CR, Robledo KP, Karapetis CS, Day FL, Nott LM, Jefford M, Chantrill LA, Pavlakis N, Tebbutt NC, Price TJ, Khasraw M, Van Hazel GA, Waring PM, Tejpar S, Simes J, Gebski VJ, Desai J, Segelov E, Cetuximab alone or with irinotecan for resistant KRAS-, NRAS-, BRAF- and PIK3CA-wild-type metastatic colorectal cancer: the AGITG randomised phase II ICECREAM study, Clin Colorectal Cancer 2018 Dec; 17(4):313-319. doi: 10.1016/j.clcc.2018.06.002. Epub 2018 Jun 8.

IDEATang M, Price TJ, Shapiro J, Gibbs P, Haller DG, Arnold D, Peeters M, Segelov E, Roy A, Tebbutt N, Pavlakis N, Karapetis C, Burge M. Adjuvant therapy for resected colon cancer 2017, including the idea analysis. Expert Review of Anticancer Therapy. 2018;18(4):339-349André T, Vernerey D, Mineur L, Bennouna J, Desrame J, Faroux R, Fratte S, Hug de Larauze M, Paget-Bailly S, Chibaudel B, Bez J, Dauba J, Louvet C, Lepere C, Dupuis O, Becouarn Y, Mabro M, Egreteau J, Bouche O, Deplanque G, Ychou M, Galais MP, Ghiringhelli F, Dourthe LM, Bachet JB, Khalil A, Bonnetain F, de Gramont A, Taieb J; for PRODIGE investigators, GERCOR, Fédération Française de Cancérologie Digestive, and UNICANCER. Three Versus 6 Months of Oxaliplatin-Based Adjuvant Chemotherapy for Patients With Stage III Colon Cancer: Disease-Free Survival Results From a Randomized, Open-Label, International Duration Evaluation of Adjuvant (IDEA) France, Phase III Trial. J Clin Oncol. 2018 May 20;36(15):1469-1477. doi: 10.1200/JCO.2017.76.0355. Epub 2018 Apr 5.

MAXMooi JK, Wirapati P, Asher R, Lee CK, Savas PS, Price TJ, Townsend A, Hardingham J, Buchanan D, Williams D, Tejpar S, Mariadason JM, Tebbutt NC. The prognostic impact of consensus molecular subtypes (CMS) and its predictive effects for bevacizumab benefit in metastatic colorectal cancer:

Molecular analysis of the AGITG MAX clinical trial. Ann Oncol. 2018; Nov 1; 29(11):2240-2246. doi.org/10.1093/annonc/mdy410Grothey A, Sobrero AF, Shields AF, Yoshino T, Paul J, Taieb J, Souglakos J, Shi Q, Kerr R, Labianca R, Meyerhardt JA, Vernerey D, Yamanaka T, Boukovinas I, Meyers JP, Renfro LA, Niedzwiecki D, Watanabe T, Torri V, Saunders M, Sargent DJ, Andre T, Iveson T. Duration of Adjuvant Chemotherapy for Stage III Colon Cancer N Engl J Med. 2018 Mar 29;378(13):1177-1188.

SCOTIveson TJ, Kerr RS, Saunders MP, Cassidy J, Hollander NH, Tabernero J, Haydon A, Glimelius B, Harkin A, Allan K, McQueen J, Scudder C, Boyd KA, Briggs A, Waterston A, Medley L, Wilson C, Ellis R, Essapen S, Dhadda AS, Harrison M, Falk S, Raouf S, Rees C, Olesen RK, Propper D, Bridgewater J, Azzabi A, Farrugia D, Webb A, Cunningham D, Hickish T, Weaver A, Gollins S, Wasan HS, Paul J. 3 versus 6 months of adjuvant oxaliplatin-fluoropyrimidine combination therapy for colorectal cancer: an international, randomised, phase 3, non-inferiority trial. Lancet Oncol. 2018 Apr;19(4):562-578.doi: 10.1016/S1470-2045(18)30093-7.

TOPGEARLeong T, Editorial - A CRITICal period for chemoradiotherapy in gastric cancer. Lancet Oncol. 2018 May;19

PresentationsIn 2018, members of the AGITG presented at international cancer conferences in the US and Europe. Showcasing AGITG trial results to international colleagues is an important focus for the AGITG at these high profile international conferences.

CO.20Shepshelovich D, Townsend AR, Espin-Garcia O, Latifovic L, O'Callaghan C, Jonker DJ, Tu D, Chen E, Morgen E, Price TJ, Shapiro JD, Siu LL, Owzar K, Ratain MJ, Kubo M, Dubrovic A, Xu W, Mushiroda T, Liu G. The association of FCGR2A and FCGR3A polymorphisms

Journal Publications & Conference Presentations

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with outcomes in cetuximab treated metastatic colorectal cancer patients: CCTG and AGITG CO.20 trial analysis. American Society of Clinical Oncology Gastrointestinal Cancers Symposium; 18–20 Jan 2018; San Francisco.

DOCTORBarbour A, Walpole ET, Mai GT, Barnes E, Watson DI, Ackland SP, Martin J, Burge M, Finch R, Karapetis CS, Shannon J, Nott LM, Varma S, Marx G, Falk G, Gebski V, Oostendorp M, Wilson K, Thomas J, Lampe G, Zalcberg JR, Simes J, Smithers M. Progression-free survival and recurrence results for AGITG DOCTOR. Pre-operative cisplatin, 5-fluorouracil (5-FU) & docetaxel +/-radiotherapy after poor early response to cisplatin & 5-FU for resectable oesophageal adenocarcinoma. European Society for Medical Oncology (ESMO) 19-23 October 2018; Munich.

InterAACTRao S, Sclafani F, Eng C, Grønlie Guren M, Adams RA, Benson A, Sebag-Montefiore D, Segelov E, Bryant A, Peckitt A, Roy A, Seymour MT, Welch J, Saunders MP, Muirhead R, Bridgewater J, Falk S, Glynne-Jones R, Arnold D, Cunningham D. InteAACT: A multicentre open label randomised phase II advanced anal cancer trial of cisplatin (CDD) plus 5-fluorouracil (5-FU) vs carbolatin © plus weekly paclitaxel (P)

in patients (pts) with inoperable locally recurrent (ILR) or metastatic treatment naiive disease - An International Rare Cancers Initiative (IRCI trial). ESMO 19-23 October 2018; Munich.

MAXTownsend AR, Asher R, Price TJ, Lee CK, Dorward H, Gebski V, Tomita Y, Tebbutt NC, Hardingham J. Single nucleotide polymorphisms in COL4A2, PPP1R17, and ARHGAPP44 and prognostic value in metastatic colorectal cancer. ASCO Gastrointestinal Cancers Symposium; 18–20 Jan 2018; San Francisco.

NABNECChantrill LA, Lipton LR, Hofman M, Gebski V, Gill A, Markman B, Yip S, Karapetis CS, Pavlakis N, Wong SF, Ransom DT, Sjoquist KM, Nagrial A, Michael M, Rayani U, Oostendorp M, Simes J, Khasraw M. AGITG NABNEC: A randomised phase II study of nab-paclitaxel in combination with carboplatin as first line treatment of gastrointestinal neuroendocrine carcinomas. ASCO Gastrointestinal Cancers Symposium; 18–20 Jan 2018; San Francisco.

PETACC 6Schmoll H-J, Haustermans K, Price TJ, Nordlinger B, Hofheinz R, Daisne J-F, Janssens J, Brenner B, Schmidt P, Reinel H, Hollerbach S, Caca K, Fauth FWB, Hannig C, Zalcberg JR, Tebbutt NC, Mauer ME, Marreaud S,

Lutz MP, CutseM EV. Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine +/- oxaliplatin in locally advanced rectal cancer: Final results of PETACC-6. ASCO Annual Meeting; 1-5 June 2018; Chicago.

SCOTBlinman P, Martin A , Jefford M, Goldstein D, Boadle D, Morris M, Tebbutt N, Aiken C, Segelov E, Paul J, Haydon A, Iveson T, Stockler M. AGITG SCOT: Patients’ preferences for 3 months versus 6 months of adjuvant chemotherapy for colon cancer in the SCOT trial: what survival benefits make longer chemotherapy worthwhile? ASCO Annual Meeting; 1-5 June 2018; Chicago.

Saunders MP, Paul J, Crosby J, Brown G, Iveson T, Kerr R, Harkin A, Allan K, McQueen J, Pearson SR, Cassidy J, Medley LC, Raouf S, Harrison M, Brewster A, C. R, Ellis R, Thomas AL, Churn M, Maka N. SCOT: Tumor sidedness and the influence of chemotherapy duration on DFS. ASCO Gastrointestinal Cancers Symposium; 18–20 Jan 2018; San Francisco.

TOPGEARLeong T, Multidisciplinary approach to resectable gastric cancer. Is there a role for radiotherapy? Presented at ESMO Asia 2018 ; 23-25 November 2018; Singapore.

Journal Publications & Conference Presentations

Ross’s StoryRoss Hinscliff has been fighting for better treatments for GI cancers since his wife, Jeanine, was diagnosed in 2014. “Prior to Jeanine’s diagnosis, I hadn’t had a close relationship with anyone who had cancer,” he says. “Having someone close to you diagnosed was really eye-opening – particularly when you realise that for many, treatment options are limited and survival outcomes are still so poor.”

Jeanine lost her battle with a rare GI cancer in July, 2018. Ross continues to fight for better treatments for these cancers in her memory, and to set an example for his two teenage children.

Despite the challenges of now being a single dad of two teenagers, Ross committed to trekking over 65km through the Tasmanian Wilderness as part of the Gutsy Overland Challenge to honour his wife. He is truly committed to raising awareness and much-needed funds for research to help others in the future. “I’ve got two kids, a son who’s 15 and a daughter who’s 12, and they’ve been on this journey as well,” he says. “I want to set an example for them and having something to focus on also helps with the grieving process as well.”

Pictured: Professor Trevor Leong who presented at ESMO Asia 2018

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Follow the genesis of an AGITG clinical trial, OXTOX, from identification of the problem to obtaining funding for a study supported by the AGITG Innovation Fund. This is a phase II study investigating whether oxaliplatin dose reduction and neurotoxicity can be reduced with ibudilast in people with metastatic colorectal cancer.

Oxaliplatin chemotherapy improves survival but causes acute neuropathy (pins and needles and pain on touching or swallowing cold objects or fluids) and chronic chemotherapy-induced peripheral neuropathy (CIPN) in most people receiving the drug. This causes numbness, discomfort, and pain especially in the hands and feet, which can last for months to years after stopping treatment. Studies done using animal models suggest ibudilast, a tablet, when given with oxaliplatin can prevent and treat neurotoxicity. This may mean more oxaliplatin can be delivered, thus improving survival in people with colorectal cancers.

Step �. Identify a gap in researchIn her role leading the Sydney Survivorship Centre, Professor Janette Vardy was surprised

when outcomes indicated how big an issue peripheral neuropathy was for cancer patients. She was interested in looking into this further.

Step 2. Review the literatureA search for information on the treatment for peripheral neuropathy showed that there was

no evidence-based treatment available. There was a distinct gap in knowledge.

Step �. Conduct pre-clinical researchProfessor Vardy’s PhD student Dr Christina Teng was studying peripheral neuropathy. Together

with Dr Ian Johnston at the University of Sydney, they conducted an animal study which found that ibudilast was successful in reducing peripheral neuropathy in rats.

Step �. Conduct a pilot studyResearchers conducted a pilot study looking at the impact of ibudilast on patients to ensure

that it was a safe treatment. This was a pharmacokinetic study that also collected data on patient-reported outcomes including peripheral neuropathy.

Step �. Assemble a research teamProfessor Vardy assembled a research team, a mixture of medical oncologists and researchers

that had the knowledge to move the concept forward. Five clinicians from sites with a focus on colorectal cancer treatment joined the team as they recognised that this was such a huge problem for their patients for which there is very little evidence-based treatment.

Step �. Apply to the AGITG Innovation FundProfessor Vardy prepared a grant application for the 2018 AGITG Innovation Fund and was

awarded a $200,000 grant. The AGITG Innovation Fund is made possible by the generosity of donors.

Step �. A clinical trial is startedThe phase II clinical trial will be open to recruitment in 2019 with funding from the

AGITG Innovation Fund. This was the last step in a process that began with Professor Vardy noticing a problem that was substantially affecting patients who did not have other treatments available.

Pictured: Professor Tim Price congratulating Dr Christina Teng on receiving the 2018 Innovation Fund Award

To successfully obtain funding for academic research and to establish a clinical trial takes a considerable amount of effort, time and collaboration across multi-disciplinary teams.

Genesis of a Clinical Trial

Trine’s StoryIn 2018 Trine Simpson raised over $22,000 for stomach cancer research in memory of her husband, Matt. Matt was diagnosed with linitis plastica, a rare form of stomach cancer, in October 2012 and passed away in November 2013 aged just 40 years old, leaving behind a young family. Trine set up the Silly Hat for Matt Gutsy Challenge specifically to honour Matt and highlight the need for more research in to stomach cancer.

“I will never be able to have an answer for our boys when they ask me why their dad got sick and why he could not be cured – why it had to be him. But I’m hoping that in some way, what we are all doing here will help

others in the future to not have to answer those same questions about their loved ones because of the availability of far better treatment options,” says Trine.

“And despite the very sad reason why we are doing this challenge, it is also wonderful to do this in Matt‘s memory, and to be able to share stories and to remember a man who was always there for everyone and who always brought people together making sure they had a good time. Even in his glaring absence, he’s still managing to do exactly that.”

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The AGITG held its 20th Annual Scientific Meeting at the Brisbane Convention and Exhibition Centre from 31 October – 2 November 2018.

Cutting-edge GI cancer therapies and treatments were key points of discussion at the meeting. Invited speakers shared insights on topics as diverse as molecular pathology, understanding molecular and immunological targets, the microbiome, variations in treatment around the world, and how to interpret data as statistically or clinically relevant. The program was balanced between education around multidisciplinary controversies and AGITG trial updates.

The Principal Investigators of AGITG trials updated the group on our research. New research included the DYNAMIC studies, which are analysing the potential of circulating tumour DNA in GI cancer. Another new trial presented was the MODULATE study investigating whether immunotherapy could be used to treat colorectal cancer. In upper GI cancers, the MASTERPLAN trial investigating stereotactic body radiotherapy in pancreatic cancer was presented. It was exciting to see so much progress in a wide variety of therapeutic areas.

The Meeting began with a fascinating keynote breakfast session sponsored by Merck. Professor Sabine Tejpar presented on, ‘Taking sides in colorectal cancer: Predictive and prognostic factors in selecting therapy’.

This was followed by the Opening Plenary sponsored by Amgen Australia. Four esteemed speakers discussed the best treatments for colorectal cancer from the perspectives of gastroenterology, surgery, radiation oncology and medical oncology. Later in the day, the colorectal cancer

multidisciplinary workshop sponsored by Servier provided food for thought by showcasing controversial areas of diagnosis and management, with an expert panel and audience interaction.

In the afternoon, the Trainees Workshop was a unique opportunity for early career professionals to meet with senior and successful medical, surgical and radiation oncologists who have followed varied paths to their current positions. It explored the many different opportunities available to trainees and how to navigate them.

The second day focused on translational research. Professor Aldo Scarpa presented, ‘What light through yonder window breaks: The dawn of routine molecular pathology’. He spoke about molecular and morphologic aspects of modern pancreas cancer pathology, and the opportunities and limitations of genomics-driven cancer care. Afterwards, at the Translational Science Symposium, the focus was on evolving insights into molecular and immunological targets in GI cancers.

The New Concepts Symposium was a stimulating forum for robust discussion and development of research concepts. This forum provides an opportunity for delegates to present embryonic new concepts for feedback and discussion with the audience as well as comments from international guests in terms of perspective, international interest and relevance. Ten concepts were submitted this year and four were chosen for presentation. Dr Lorraine Chantrill was presented the Best New Concept Award sponsored by Specialised Therapeutics for her concept titled, ‘A pilot feasibility and discovery study of neoadjuvant FOLFIRINOX followed by immunotherapy for resectable adenocarcinoma of the pancreas’.

The Joint Consumer and Study Coordinator Forum was another highlight. There were presentations on liquid biopsies, rare cancers, a day in the life of a trials manager, and health economics. We also heard about how tele-trials are reaching rural patients and how financial toxicity means that out of pocket expenses may influence treatment decisions. At the 20th Annual Meeting Dinner on Thursday night, Professor Janette Vardy was awarded the annual AGITG Innovation Fund grant for the OXTOX trial.

We were honoured to host a stellar line-up of invited faculty including:

Prof Sabine Tejpar Medical Oncologist, University Hospital Leuven, Belgium

Prof Brendan MoranColorectal Surgeon, Basingstoke and North Hampshire Hospital, UK

Prof Daniel ChangRadiation Oncologist, Stanford University, USA

Prof Aldo ScarpaPathologist, University of Verona, Italy

Prof Diana SarfatiEpidemiologist, University of Otago, NZ

Prof Jae-Ho CheongSurgeon-Scientist, Yonsei University College of Medicine, South Korea

Prof Graeme YoungGastroenterologist, Flinders University, SA

Dr Daniel RenoufMedical Oncologist, University of British Columbia, Canada

Annual Scientific Meeting

Pictured: Professor Also Scarpa, presenting at the AGITG Annual Scientific Meeting

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Over the past four years, working with the ASM Executive Committee to develop a meeting that delivers high value content for AGITG members, has been both professionally and personally rewarding. Thank you to the many colleagues who have contributed both time and expertise during my tenure.

Professor Eva Segelov 2018 Meeting Convenor

Platinum Sponsor

Gold Sponsors

Silver Sponsors

Bronze Sponsors

Professor John Simes was recognised for his invaluable contributions to the AGITG over 27 years, and received the John Zalcberg OAM Award for Excellence in AGITG Clinical Trials Research.

The Keynote Breakfast Session the next morning, sponsored by Bayer, was one of the Meeting’s highlights. The speakers explored the disparity between real-world patients and those who are recruited to randomised studies, and what healthcare practitioners could learn from real-world variations in care.

Professor Diana Sarfati gave a captivating presentation on statistical fallacies and the difference between clinical and statistical significance. Professor Jae-Ho Cheong explained the variations in clinical practice in the management of oesophagogastric cancer between East and West, and Professor Sabine Tejpar presented,

‘Microbiome and Mapping: Are we what we eat?’

AGITG trials were presented in updates across the three days:

• Colorectal and anal cancer trials including updates on A La CaRT, SPAR, DYNAMIC-Rectal & DYNAMIC-III, ASCOLT, RENO, MODULATE, LIBERATE, MONARCC and InterAACT.

• Upper GI, hepatobiliary, GIST and NET cancer trials including INTEGRATE II, DOCTOR, GAP, ACTICCA-1, CONTROL NETs, NABNEC and TOPGEAR, and plans for the MASTERPLAN trial.

It was Professor Eva Segelov’s final year as Meeting Convenor and she was recognised for the passion and energy she has brought to the Meeting as Convenor since 2015. We welcomed Dr Lorraine Chantrill as the incoming Convenor for 2019 and beyond. Over 350 delegates attended the Meeting this year, a record number for the AGITG. The energy and collegiate atmosphere was evidence of the passion of the GI cancer research community which the AGITG is proud to support. Pictured (Top L-R): Dr Amy Davis and Dr Amitesh Roy

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research that could help unlock immunotherapy for colorectal cancer patients.

Dr Habib received a $36,700 grant to fund the first year of her PhD research. She will study genetically engineered immune cells known as chimeric antigen receptor (CAR) T-cells, which target abnormal clones of immune cells.

Triggering this immune response has produced cures in otherwise incurable leukaemia and lymphoma, and Dr Habib’s research will investigate how it could be applied to colon cancer by testing CAR T-cells and then using them to target tumour cells. Currently, colon cancer cannot be treated with immunotherapy.

“I would like to thank the AGITG, in partnership with Merck, for awarding me the Kristian Anderson scholarship,” said Dr Habib. “I am grateful for the opportunities this award will provide in allowing me to dedicate my time towards research.

“I will endeavour to improve on the current standard of care in colorectal cancer, a cancer of unmet need, by developing targeted CAR T-cells.”

Kristian Anderson was diagnosed with cancer in his bowel and liver in October 2009. He successfully lobbied the federal government to subsidise the drug cetuximab after it prolonged his life. He passed away in January 2012, leaving behind a legacy as a man who improved the treatment of many colon cancer patients.

Merck Australia’s Acting Managing Director and Regional Vice President Healthcare APAC, Andre Musto, stated, “The Merck-AGITG Krisitan Anderson Award is part of the company’s dedication to furthering clinical research in Australia and New Zealand. The Award is important recognition of the legacy of Kristian Anderson and his family in the treatment and prevention of bowel cancer.”

Dr Lorraine Chantrill, Best New Concept Award

New Concepts SymposiumThe New Concepts Symposium at the AGITG Annual Scientific Meeting is sponsored by independent biopharmaceutical company Specialised Therapeutics, a key demonstration of its commitment to cancer research and the development of new therapeutics that may change lives.

At the New Concepts Symposium, delegates present embryonic new concepts for feedback and discussion with the audience. They receive comments from international faculty regarding the perspective, international interest and relevance of their concepts.

Professor Janette Vardy, AGITG Innovation Fund Award

AGITG Innovation Fund Professor Janette Vardy from the School of Medicine at the University of Sydney was awarded the AGITG Innovation Fund in 2018. She received a $200,000 grant for her pilot study titled, ‘OXTOX: Can oxaliplatin dose reduction and neurotoxicity be reduced with ibidilast in people with metastatic colorectal cancer?’

The AGITG Innovation Fund is made possible through generous contributions from the Spencer Gibson Foundation, the His Honour Alan Bishop Fund and with donations raised through the GI Cancer Institute’s Gutsy Challenge.

Currently, patients with advanced colorectal cancer often receive a kind of chemotherapy called oxaliplatin. This is an effective therapy which improves survival, but it causes acute neuropathy. Neuropathy is nerve damage that causes numbness, discomfort and pain in patients’ hands and feet, or pins and needles and pain on touching or swallowing cold objects or fluids.

Professor Vardy believes that the tablet ibudilast could prevent and treat neurotoxicity, meaning that patients will not suffer from as much neuropathy. As well as improving their quality of life, it could enable them to have more chemotherapy and improve their survival.

“We are very grateful to the AGITG and the donors who have supported our study investigating an intervention for chemotherapy-induced peripheral neuropathy,” says Professor Vardy.

“Preliminary data in our phase one study looks promising. We hope to be able to reduce the incidence and severity of peripheral neuropathy associated with oxaliplatin.”

Dr David Lau (centre), Merck-AGITG Clinical Research Fellow, pictured with Professor Tim Price (left) and Mr Drew Young (right) from Merck.

Merck-AGITG Clinical Research FellowshipIn 2017, the inaugural Merck-AGITG Clinical Research Fellowship in Gastro-Intestinal Cancer was awarded to Dr David Lau, a clinician-scientist at the Olivia Newton-John Cancer Research Institute, Austin Hospital Melbourne.

Dr Lau began his fellowship at the Royal Marsden Hospital in London in September 2018. As well as contributing to efforts to develop further collaboration between the AGITG and leading research institutes in the United Kingdom, it has provided him with the opportunity to learn from experts in GI cancer.

Merck provided a $150,000 grant to the AGITG to be awarded over two years to support the Fellowship. The Managing Director of Merck Biopharma in Australia and New Zealand, Mr Drew Young, said, “We congratulate Dr Lau on this award. Merck is very pleased to support research in GI cancer and this Fellowship provides a way to advance knowledge in this important therapy area and build links that will ultimately help to deliver better outcomes for Australian patients. We have a long-standing commitment to helping patients with colorectal cancer as

well as a significant R&D investment in a rapidly evolving pipeline of potential new cancer therapies.”

In December 2018, Dr Lau described the first three months of his fellowship as “incredible”.

“It’s exceeding my expectations of the job,” he said. “At the Marsden every day we live and breathe clinical trials, so being on the job has given me experience in initiating and running clinical studies. What has been very useful has been the collaborative environment in which the Marsden is positioned. There is close collaboration with the Institute for Cancer Research who are helping to make breakthroughs in the laboratory.”

Before taking on the fellowship, Dr Lau’s primary focus for his research was discovering new molecular targets in biliary tract cancer cell lines using next generation sequencing. He also contributed to the INTEGRATE trial, which won an AGITG Innovation Grant in 2015 and a NHMRC Project Grant in 2017.

“The outcomes of GI cancers are improving but we can still do a lot better,” said Dr Lau. “We urgently need new treatments, new discoveries, and better ways of treating them to improve outcomes for patients. I’m hoping to contribute to that.”

Dr Rosemary Habib, Merck-AGITG Kristian Anderson Award

Merck-AGITG Kristian Anderson AwardDr Rosemary Habib has been awarded the Merck-AGITG Kristian Anderson Award for her

Pictured (Top L-R): Ms Nikoletta McLeod, Dr Lorraine Chantrill receiving her award, Professor Tim Price and Dr Shane Patella

Investing in Research

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Dr Lorraine Chantrill was awarded the Best New Concept Award at the 2018 Symposium for her concept titled, ‘A pilot feasibility and discovery study of neoadjuvant FOLFIRINOX followed by immunotherapy for resectable adenocarcinoma of the pancreas’.

This concept aims to investigate giving chemotherapy before surgery and then immunotherapy after surgery for pancreatic cancer patients. Pancreatic cancer currently has one of the lowest survival rates of all cancers. Just 8.7% of patients survive for more than five years after their initial diagnosis.

“There is a desperate need for better treatments for pancreatic cancer and I am proud that my concept has been acknowledged as a valuable contribution to research in this area,” Dr Chantrill said. “I am thankful to the AGITG and our donor supporters and I look forward to developing this concept further.”

The AGITG thanks Specialised Therapeutics for their continued support of the New Concepts Symposium and Best New Concept Award.

Dr Belinda Lee, Best of Posters

Best of Posters The AGITG Annual Scientific Meeting accepts abstracts for posters for selection by the Organising Committee. Posters are displayed in the exhibition area and four posters are chosen for presentation in the Best of Posters Session, sponsored by Clinical Genomics.

Dr Belinda Lee was awarded the 2018 Best of Posters Award for her poster titled, ‘Pancreatic cancer: An analysis of ‘real-world’ stent-related morbidity in the palliative setting’.

Dr Lee’s research analysed the frequency, nature and treatment implications that occurred in relation to stent insertion or surgical bypass for palliative pancreatic cancer patients. The results of this research found that stent insertion is associated with significant morbidity in the palliative setting.

“There is a great need to improve outcomes in pancreatic cancer. I look forward to being able to share the results of our future research into stent-related morbidity,” said Dr Lee. “I am delighted that the work I have been doing in pancreatic cancer has been recognised.”

Dr Frederick S. Jones, Vice President of Medical and Scientific Affairs at Clinical Genomics, stated, “At Clinical Genomics, our commitment is to enhance patient care by early detection. We are proud that this contribution to Best of Posters and the Best Fast Forward Presentation Award is able to help recognise excellent research that leads to positive outcomes for patients.”

Dr Hui-Li Wong, Fast Forward Award

Best Fast Forward PresentationDr Hui-Li Wong was awarded the Best Fast Forward Presentation Award for her concept titled, ‘Biomarker testing and biomarker-directed treatment utilisation for metastatic colorectal cancer in Australian practice’.

In the Fast Forward Session, sponsored by Clinical Genomics, delegates have just three minutes to present their research concepts.

“I am thrilled to have been awarded the Best Fast Forward Presentation Award for our study exploring the uptake of biomarker testing for metastatic colorectal cancer in Australian practice,” said Dr Wong. “This research highlights the importance of clinical registries and real-world data in understanding and improving cancer treatment, and I am grateful to the AGITG that it was able to be presented on this platform.”

Julie Constantin and Donna Haberl from the Olivia Newton-John Cancer Research Institute, Outstanding Site Award

Outstanding Site AwardThe AGITG awarded the Olivia Newton-John Cancer Wellness & Research Centre (ONJ Centre) the 2018 Outstanding Site Award. The ONJ Centre was recognised for its participation in a large number of AGITG studies over the past 20 years.

In 2018 the ONJ Centre was the first trial site to activate the MODULATE study, and was the highest recruiting site for the INTEGRATE II and LIBERATE studies.

In 2017, Principal Investigator Associate Professor Niall Tebbutt and Study Coordinator Brie Jelbart, both from the ONJ centre, took on the Mt Aconcagua Gutsy Challenge Adventure. They were part of a team with six other climbers who raised over $140,000 for the GI Cancer Institute.

Investing in Research

Participants at CommNETs

CommNETs Research Collaboration The CommNETs (Commonwealth Neuroendocrine Tumour) research collaborative had a productive 2018 including one workshop, one preceptorship, and three publications. A clinical trial workshop was held on 8-9 December in Hong Kong to develop clinical trials under the CommNETs portfolio. A total of 34 individuals were in attendance representing our three member nations (Australia, Canada, and New Zealand). A diverse group of investigators were in attendance including statisticians, patient representatives, medical surgical and radiation oncologists, endocrinologists and endocrine surgeons, allied health professionals, and individuals with expertise in health economics, correlative studies, medical physics, and patient-reported outcomes.

Nine trial proposals were presented, followed by a vote to move four trials forward to further development. The trial concepts presented ranged from investigations in surgical decision making, to hormone therapy dosing and duration, and the potential for uses of immunotherapy and radiotherapy in various combinations in neuroendocrine tumours. The multi-nation collaboration put forth by our dedicated team of professionals proved to be valuable. When the working group updates were presented we witnessed impressive transformations and feedback focused on feasibility and trial design.

As a result of the 2018 workshop, CommNETs now has two newly

developing clinical trial projects to add to their 13 existing projects. CommNETs looks forward to continuing with an Annual Meeting in early December 2019 that is not exclusive to clinical trials and continues to expand the scope of their projects.

In addition to the Clinical Trial Workshop, CommNETs hosted their second Preceptorship in collaboration with Novartis. The first CommNETs Preceptorship was held in Singapore in 2017. In 2018, 18 clinicians from across Latin America and the three CommNETs member nations met in Sao Paulo Brazil led by both local preceptors and CommNETs preceptors to review past research, discuss current treatment guidelines, and explore the potential for advances in neuroendocrine cancer care.

Dr Sayeda Naher, AGITG Research Fellow

AGITG Fellowship Program In 2018 Dr Sayeda Naher joined the AGITG as a Research Fellow.

Dr Naher has had an interest in researching GI cancers, and particularly stomach cancer, since her advanced oncology training.

“One thing that really strikes me about advanced gastric cancer is that there are really poor prognoses,” she says. “I think there is a lot of scope to increase prognosis and quality of life.”

The AGITG Research Fellowship is an opportunity for oncologists who have completed oncology training to conduct clinical trials in their areas of interest. Dr Naher’s decision to apply for the Fellowship

was motivated by an interest in the clinical trial process itself, and a desire to gain more first-hand experience in conducting clinical trials.

“I think clinical trials are the best way to define and see evidence,” she says. “I think this Fellowship will give me the opportunity to see how a clinical trial is developed, how the trial runs and what the pros and cons of a clinical trial are.”

Research fellows provide day-to-day clinical support by adjudicating on eligibility, treatment, and adverse effects. They work to design, conduct and report large-scale clinical trials in GI cancer. As well as developing trial concepts and protocols, and securing grants. Research Fellows develop reports, meeting presentations, and journal articles, monitoring and contributing to the latest developments in cancer research.

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Infrastructure GrantsFunds provided by Cancer Australia to support AGITG infrastructure are managed by the University of Sydney NHMRC Clinical Trials Centre. These funds are not reported in the financial accounts of the AGITG, unless transferred to support of specific AGITG expenses.

Funding• Cancer Australia infrastructure

grants: During the 2017 year a further extension was granted to 30 June 2018. From these grant extensions the AGITG received $230,800 to support infrastructure costs for the financial year.

During the 2018 year, Cancer Australia confirmed a new 3 year Infrastructure Grant from 1 July 2018 to 30 June 2021. This new grant is in collaboration with the University of Sydney NHMRC Clinical Trials Centre and will provide the AGITG $750,000 in infrastructure funding over the grant period.

Research GrantsFunds provided by Cancer Australia, Cancer Council and the National Health and Medical Research Council in support of trial coordination are also managed by the University of Sydney NHMRC Clinical Trials Centre. Funds to support site payments and insurance costs relating to these studies are transferred to the AGITG and are reflected in these financial accounts.

Grants supporting trials conducted during the 2018 financial year are outlined below. AGITG grant income and expenditure during the 2018 year for these trials are included in the 2018 Income Statement.

ACTICCA-1 A multi-centre, prospective, randomised, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. observation alone in patients after curative intent resection of Biliary Tract Cancer (BTC).

Funding• Cancer Australia Grant: $163,600

(2016)

ALaCaRT A phase III prospective randomised trial comparing laparoscopic assisted resection versus open resection for rectal cancer.

Funding• NHMRC Grant: $932,586 (2011) • NHMRC Grant: $573,259 (2015)

ASCOLTAn international randomised, double blind, placebo controlled phase III multi-centre 0trial, investigating the effect of aspirin on disease free and overall survival as adjuvant treatment in patients with resected stage II and III colorectal cancer.

Funding• Cancer Australia and Bowel Cancer

Australia Grant: $328,000 (2014)• National Cancer Centre of

Singapore: USD$100,000 (2016)• National Cancer Centre of

Singapore: USD$100,000 (2018)

ASCOLT Translational StudyA translational study of samples collected on the international ASCOLT adjuvant colorectal cancer aspirin trial.

FundingPerpetual Trustee Company Limited (2015)

• The Jessica & Wallace Hore Foundation: $25,000

• Elaine Haworth Charitable Endowment: $41,522

• The Merrett Endowment: $35,922

CONTROL NETSCapecitabine ON Temozolomide Radionuclide therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study.

Funding• Unicorn Foundation: $200,000

(2015), and $105,000 (2017) • University of Sydney Bridging

Grant: $30,000 (2015)

DOCTORA randomised phase II trial of pre-operative cisplatin, 5-fluorouracil and docetaxel or cisplatin, 5-fluorouracil, docetaxel plus radiotherapy based on poor early response to standard chemotherapy for resectable adenocarcinoma of the oesophagus and/or oesophageal junction.

Funding• NHMRC Grant: $387,000 (2011)

DYNAMIC-IIIA study is to compare treatment informed by ctDNA results to standard care in patients with stage III colon cancer.

Funding• Walter and Eliza Hall Institute

$131,787 plus site payments (2017)

DYNAMIC – PANCREASA study to demonstrate that a ctDNA informed approach to chemotherapy, following surgery for localised pancreatic cancer, could lead to a reduction in the proportion of patients with detectable ctDNA after completion of treatment compared to standard of care.

Funding• Walter and Eliza Hall Institute

$83,107 plus site payments (2018)

DYNAMIC – RECTALThis initial study has been designed to determine whether a ctDNA-based approach to adjuvant therapy will lead to substantially less patients receiving adjuvant therapy.

Funding• Walter and Eliza Hall Institute

$85,107 plus site payments (2017)

MASTERPLANThis study aims to determine if adding stereotactic body radiotherapy (SBRT) to modern chemotherapy (mFOLFIRINOX or gemcitabine/nab-paclitaxel) for patients with high-risk or unresectable (also called locally advanced) pancreatic cancer improves cancer control rates in and around the pancreas.

Funding• Medical Research Future Fund:

$1,512,808 (2018)

NABNEC A Randomised Phase II Study of NAB-Paclitaxel In Combination With Carboplatin As First Line Treatment of Gastrointestinal Neuroendocrine Carcinomas.

Funding• NHMRC project grant: $360,750

(2016)

SCOT Short Course Oncology Therapy - A study of adjuvant chemotherapy in colorectal cancer.

Funding• NHMRC Grant: $399,700 (2009)

SPARSimvastatin with chemotherapy and radiation in preoperative treatment for rectal cancer: a randomized, placebo-controlled phase 2 trial.

Funding• CSNZ Grant: $149,000 (2015)• CCNSW Grant: $450,000 (2016)• CA Grant: $147,000 (2017)

TOPGEAR NHMRCA randomised phase II/III trial of pre-operative chemoradiotherapy versus pre-operative chemotherapy for resectable gastric cancer.

Funding • NHMRC Grant: $756,136 (2013)

Pictured: Professor Stephen Ackland, presenting at the AGITG Annual Scientific Meeting

Grants

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Professor John Simes (retired May 2018)Group CoordinatorBSc MBBS SM FRACP MDJohn is the Senior Principal Research Fellow and Director of the NHMRC Clinical Trials Centre, University of Sydney and Director of the AGITG Coordinating Centre, located within the NHMRC Clinical Trials Centre. He is Professor of Clinical Epidemiology in the School of Public Health at the University of Sydney and a Medical Oncologist at Royal Prince Alfred Hospital, Sydney. John has been a founding member of AGITG and member of the board since 1996.AGITG Committee Positions:Member, Scientific Advisory Committee

Professor Trevor LeongCompany SecretaryMBBS, MD, FRANZCR

Trevor is a Consultant Radiation Oncologist and past Director of Radiation Oncology at Peter MacCallum Cancer Centre. He is an academic radiation oncologist, actively involved with clinical research programs and has been a Principal Investigator in numerous phase I, II and III studies relating to gastro-intestinal malignancies. He has been involved with AGITG activities for over 15 years as a trial investigator, member of the SAC, and Board member.AGITG Committee Positions:Member, Corporate Governance CommitteeMember, Upper GI Working PartyMember, Scientific Advisory Committee

Professor Tim Price Chair MBBS DHthSc (Med) FRACP Tim is Senior Consultant Medical Oncologist and Director of Medical Oncology and Clinical Cancer Research at The Queen Elizabeth Hospital in Adelaide. His major clinical interest is in treatment of patients with GI cancer and he is currently involved in an extensive GI clinical trial program. He is Professor at the University of Adelaide and Colorectal Cancer Stream leader for South Australian Health and Medical Research Institute, and leads the GI translational and laboratory research laboratory at the Basil Hetzel Institute. He chairs the current national NHMRC Cancer Council Colorectal Guidelines committee which led to the recently published updated guidelines. He is also a visiting/honorary Professor at University of Sydney and University of Antwerp, Belgium.AGITG Committee Positions:Chair, Scientific Advisory CommitteeMember, Corporate Governance CommitteeMember, Upper GI Working Party

Associate Professor Niall TebbuttDeputy Chair & TreasurerPhD MRCP FRACP

Trained at Oxford University in the UK, Niall has extensive experience in the management of patients with GI cancer. He has a strong involvement in clinical research and has initiated several investigator-led or AGITG-led clinical trials. He is Director of Medical Oncology at the Olivia Newton-John Cancer Research and Wellness Centre and has published over 140 manuscripts. He has also led 2 fundraising climbs of Mount Kilimanjaro and Mt Aconcagua collectively raising over $280,000 for GI cancer research.AGITG Committee Positions:Chair, Finance & Risk Management Committee Chair, Lower GI Working Party Member, Scientific Advisory Committee

Pictured (L-R) Board of Directors: Top Row: Professor Stephen Ackland, Professor Bridget Robinson, Mr Dan Kent, Professor Trevor Leong, Professor Eva Segelov, Professor Andrew Barbour, Mr Michael Gordon. Bottom Row: Dr Lorraine Chantrill, Associate Professor Niall Tebbutt, Professor Tim Price, Ms Christine Liddy, Ms Liz Thorp.

Board of Directors

“I am proud to chair a Board of Directors with such a high level of expertise and passion. Having the opportunity to work with a group of such qualified professionals who are highly committed to GI cancer research is a privilege.”Professor Tim Price, Chair, Board of Directors

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Mr Michael GordonBBus Michael is an independent company director serving on the boards and committees of companies in the financial industry. He is a Director of Total Risk Management Pty Limited, a subsidiary of Russell Investments, which is trustee of the Russell Investments SuperSolution Master Trust. Michael also chairs the Investment Committee. Michael is an independent non-executive Director at Yarra Capital Management, a Melbourne based investment manager where he also chairs the Investment Risk And Oversight Committee. Michael sits on both the Investment Advisory Committee of Altius Investment Management in Sydney as well as the Investment Committee for a large family office based in Brisbane. He has had a distinguished career as a leading investment professional with Perpetual, BNP Paribas, Fidelity International and Schroders.AGITG Committee Positions:Member, Finance & Risk Management Committee Member, Public Affairs, Marketing & Fundraising Committee June 2017

Mr Dan KentGrad.Dip.Mgmt Dan retired as Chair of the AGITG/GI Cancer Institute Consumer Advisory Panel (CAP) in May 2017 – a role he had undertaken for six years after joining the CAP as a founding member in 2008. In 2015 Dan was presented with the inaugural John Zalcberg OAM Award for Excellence in AGITG Clinical Trials Research in recognition of his significant and outstanding leadership contribution to AGITG research over a sustained period. Dan brings a wealth of experience through his active involvement in the AGITG and GI Cancer Institute in a leadership capacity, his involvement in other external groups, and his managerial experiences (Director of Bundaberg Distilling and Bundaberg Rum companies, 1988-2000). Dan is also a Fellow of the Certified Practising Accountants and the Australian Institute of Management, and brings his lived experience as a GI T2N1M0 rectal cancer survivor.AGITG Committee Positions:Chair, Consumer Advisory Panel (2011-17)Member, AGITG Scientific Advisory Committee (2011-2017) Member, Lower Working Party (2001 – 2017)Member, Finance & Risk Management CommitteeMember, Public Affairs, Marketing & Fundraising CommitteeMember, Corporate Governance Committee

Professor Eva SegelovMBBS (Hons1) FRACP PhD Eva is a Medical Oncologist and is Director of Oncology at Monash University and Monash Health, Melbourne, Victoria; previously Senior Medical Oncologist at St Vincent’s Hospital, St Vincent’s Private Hospital and St Vincent’s Clinic and Associate Professor of Medicine, University of New South Wales. She has an interest in academic clinical trials in GI and breast cancer and has been a member of the AGITG since 2003. She has clinical trials expertise, links with national and international trials groups, and extensive experience with adult medical education.AGITG Committee Positions:Chair, Annual Scientific Meeting (ASM) Organising CommitteeChair, Education CommitteeMember, Scientific Advisory CommitteeMember, Lower GI Working PartyCommNETS Convenor

Ms Christine McNamee Liddy AOFAICD BA UNSW Christine is a former Board Member and past President of the Royal Flying Doctor Service (RFDS) of Australia and former National Vice President of the RFDS. She is also a member of the Board of the University of NSW Foundation and Member of the Advisory Board, Faculty Arts & Social Sciences, UNSW and the Dame Pattie Menzies Foundation. She is a Fellow and Council Member of St John’s College within the University of Sydney and a Council Member of the Friends of the Sydney International Piano Competition, an Advisory Board Member of the Mosman Art Gallery, and former member of the Digitization Committee of the State Library of NSW and the RFDS Capital Campaign Committee. Christine is also a former Board Member Frontline Defence Services Australian Army and Air force and former Secretary of the Art Gallery Society of NSW. Currently, she is Managing Partner Australian Plantscapes and former Managing Partner of All Purpose Indoor Plant Hire.AGITG Committee Positions:Chair, Public Affairs, Marketing & Fundraising CommitteeChair, Corporate Governance CommitteeMember, Finance & Risk Management Committee

Professor Bridget Robinson BMedSc MD (Otago) FRACP Bridget graduated in Medicine from the University of Otago, then undertook postgraduate training and MD research at the Royal Marsden Hospital and Institute for Cancer Research in London, before returning to a position as Medical Oncologist at Christchurch Hospital. Since 1998 she held a joint appointment at the University of Otago and the CDHB, and in 2010 was appointed to the Mackenzie Chair in Cancer Medicine. She initiated and directs the Cancer Society Tissue Bank to support research, and is clinical director of the Mackenzie Cancer Research Group. Her research interests include colorectal cancer, tumour stroma and the effects of obesity, coagulation in cancer, familial cancer, translational research, as well as clinical trials in cancer patients. Her clinical practice includes breast and colorectal cancers, neuroendocrine tumours (NETs), sarcomas including gastro-intestinal stromal tumours (GIST). She chairs the Canterbury Comprehensive Cancer Centre.AGITG Committee Positions:NIL

Professor Stephen AcklandMBBS, FRACP, GAICD

Stephen is a Medical Oncologist based in Newcastle, Director of Hunter Cancer Research Alliance, and Editor-in-Chief of Asia Pacific Journal of Clinical Oncology. As a member of the Australian Institute of Company Directors since 2007, he has had roles on 3 not-for-profit boards (including Chairman, ANZBCTG 2015-2017, and 1 small biotech start-up). He has had many engagements with organisations and committees involved in cancer research, particularly clinical trials and in GI cancer. In AGITG he has been a member of the Scientific Advisory Committee from 1995 to present, and Chief Investigator on the Asymptomatic Metastatic Colorectal Cancer study, co-investigator on the T3 rectal study, the MAX study, the GOFURTGO study. He is currently the Australian Chief Investigator, together with Michael Jameson (NZ), of the SPAR study, which was activated in early 2018.AGITG Committee Positions:Member, Lower GI Working PartyMember, Public Affairs, Marketing & Fundraising Committee

Dr Lorraine ChantrillB.Sc.(Hons) MBBS(Hons) FRACP PhD Lorraine is Senior Staff Specialist Medical Oncologist at St Vincent’s Hospital and the Clinical Director of Medical Oncology Clinical Trials at St Vincent’s Hospital. She has served on the AGITG Upper GI Working Party since its inception in 2011 and has chaired the Upper GI Working Party since August 2014. She was appointed to the Board of Directors of AGITG in August 2016. Lorraine is co-chair of the AGITG/Australasian Pancreatic Club Pancreas Cancer Research Workshop (since 2013) and an executive member of the Australian Pancreatic Cancer Genome Initiative. She has been appointed to the Data Safety Monitoring Board of the Australasian Leukaemia and Lymphoma Group. She completed a PhD by research in the Pancreatic Cancer Research Group at The Kinghorn Cancer Centre and has a special interest in the molecular biology of pancreas cancer.AGITG Committee Positions:Chair, Upper GI Working PartyMember, Scientific Advisory CommitteeCo-Chair, AGITG-APC Pancreas Cancer Research WorkshopMember, Public Affairs Committee

Professor David Watson (retired May 2018)MBBS MD PhD FRACS FAHMS David is Professor of Surgery in the College of Medicine and Public Health at Flinders University and an Oesophago-gastric Surgeon at Flinders Medical Centre. His research interests include clinical and biological aspects of benign and malignant oesophageal disease, including molecular biology of Barrett’s oesophagus and oesophageal carcinoma. David is a past President of the Australia and New Zealand Gastric and Oesophageal Surgery Association.AGITG Committee Positions:Member, Corporate Governance CommitteeMember, Scientific Advisory Committee

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Ms Liz ThorpBA

Liz is an experienced marketing, event, sponsorship and sports marketing professional with a successful career working with leading Australian tourism, financial services, and not-for-profit organisations. Liz is also the first female to be accredited as an agent by the Australian Cricketers Association and the Rugby Union Players Association allowing her to combine her marketing skills with business acumen to provide pathways for Australia's leading male and female cricketers, rugby union players, cyclists and netballers. With a particular focus on women in sport and the progression of women in sport during the digital broadcast revolution, Liz is committed to seeing professional female athletes attract and retain sponsors and partners who share their athlete's vision of success. She is committed to sharing relationships and networks to ensure a great outcome for internal and external clients.AGITG Committee Positions:Member, Public Affairs, Marketing & Fundraising Committee

Professor Andrew BarbourMBBS, PhD, FRACS

Andrew specialises in the treatment of oesophageal, gastric, and pancreatic diseases, as well as melanoma and soft tissue tumours. He is a surgical oncologist at The University of Queensland with a research interest in the treatment of cancer. As a clinical researcher, he has been active in the conduct of clinical trials at Phase I, II and III levels. He is the Principal Investigator for investigator-initiated, multicentre phase II trials in oesophageal (DOCTOR) and pancreatic cancer (GAP), funded by the NHMRC, MASTERPLAN, funded by the MRFF, and the DOCTOR Genomics Study, sponsored by the AGITG. These studies are aimed at developing personalised, precision therapy for cancer. Andrew is a translational researcher at the School of Medicine, The University of Queensland. He is the head of Surgical Oncology Lab at the School of Medicine. AGITG Committee Positions:Deputy Chair, Upper GI Working PartyMember, Scientific Advisory Committee

Pictured (L-R): Dr Lorraine Chantrill, Professor Stephen Ackland, Dr Belinda Lee

Operations Executive

Committee

BOARD OF DIRECTORS

Consumer Advisory Panel

Scientific Meeting

Committtee

Scientific Advisory

Committee

Independent Data Monitoring

Committee

Finance & Risk Management

Commitee

Chief Executive

Officer

International Development

Committee

Corporate Governance Committee

FinanceMarketing,

Fundraising & Communications

Administration

Trial Management Committees

Lower GI Working Party

Upper GI Working Party

Public Affairs, Marketing & Fundraising Committee

AGITG & GI Cancer Institute Organisational Structure

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Scientific Advisory CommitteeThe AGITG has an appointed Scientific Advisory Committee (SAC) chaired by Professor Tim Price.

The SAC oversees the scientific research activities of the Group and is responsible for setting the strategic direction of AGITG research. The SAC is representative of the diverse medical specialities involved in the research of the Group including medical, surgical and radiation oncology, biological research, statistics, nutrition and health consumers. The SAC membership was renewed in December 2018 to reflect the changing needs of the organisation.

We look forward their future participation and contributions to AGITG research.

Upper GI and Lower GI Working PartiesThe AGITG’s Upper GI and Lower GI Working Parties represent the disciplines of medical oncology, surgery, radiation oncology, statistics, translational science and study coordination. The Upper GI Working Party focuses on cancers of the oesophagus, gallbladder, pancreas, stomach and liver, while the Lower GI Working Party looks at cancer of the bowel, rectum and anus.

The working parties meet bi-monthly to:

• Identify gaps in research activities; • Develop and/or facilitate new

clinical research concepts; • Review the scientific merit of

research proposals; • Explore funding and feasibility

opportunities in liaison with the Operations Executive Committee;

• Nominate Principal Investigators; • Nominate Trial Management

Committee members.

The Working Parties were renewed in May 2018 to reflect the changing needs of the organisation. We look forward to their future contributions to the development of AGITG research.

Scientific Advisory CommitteeProfessor Tim Price Chair, Medical OncologistProfessor Stephen Ackland Medical Oncologist (retired Dec. 2018)Professor Andrew Barbour Surgeon Ms Katie BentonDietitian (joined Dec. 2018)Dr Lorraine Chantrill Medical Oncologist Professor Stephen Clarke Medical Oncologist (retired Dec. 2018)Dr Daniel CroaghSurgeon (joined Dec. 2018)Professor Michael Findlay Medical Oncologist Professor Val Gebski Statistician Conjoint Professor David Goldstein Medical Oncologist Associate Professor Chris HemmingsMolecular Pathology (joined Dec. 2018)Mr Peter Hewett Surgeon (retired Dec. 2018)Professor David Joseph Radiation Oncologist (retired Dec. 2018)Mr Dan Kent AGITG Board (retired Dec. 2018)Dr Andrew KneeboneRadiation Oncologist (joined Dec. 2018)Professor Trevor Leong Radiation Oncologist Ms Christine Liddy AO AGITG Board (retired Dec. 2018)Mrs Jan Mumford Chair, Consumer Advisory Panel Professor Bridget Robinson Medical Oncologist (retired Dec. 2018)Dr Tarik SammourSurgeon (joined Dec. 2018)Professor Eva Segelov Medical Oncologist (retired Dec. 2018)Dr Jennifer Shannon Medical Oncologist (retired Dec. 2018)

Professor John Simes Medical Oncologist Dr Katrin Sjoquist Medical Oncologist Ms Anne Smith Clinical Research Manager (retired Dec. 2018)Clinical Professor Nigel Spry Radiation Oncologist (retired Dec. 2018)Dr Andrew Stevenson Surgeon Associate Professor Jeanne TieTranslational Clinician (joined Dec. 2018)Associate Professor Niall Tebbutt Medical Oncologist Professor David Watson Surgeon (retired Dec. 2018)Dr Sonia Yip Oncology Translational Researcher (retired Dec. 2018)Professor John Zalcberg OAM Medical Oncologist Professor Nik Zeps Biological Scientist

Upper GI Working Party Dr Lorraine Chantrill Chair, Medical OncologistProfessor Andrew Barbour Deputy Chair, Surgeon Miss Rebecca AsherStatistician (joined Dec. 2018)Professor Alexander Boussioutas Gastroenterologist Ms Katie Benton Dietitian Dr Yu Jo Chua Medical Oncologist Professor Jonathan FawcettSurgeon (retired Dec. 2018)Professor Michael Findlay Medical Oncologist Professor Val Gebski Statistician Dr Koroush HaghighiSurgeon (retired Dec. 2018)Professor Trevor LeongRadiation Oncologist (retired Dec. 2018) Dr Dominique LeeRadiation Oncologist (joined Dec. 2018)

Professor Barbara LeggettHepatologist (joined Dec. 2018)Associate Professor Lara Lipton Medical Oncologist Professor John LubelHepatologist (joined Dec. 2018)Professor John MariadasonTranslational Science (joined Dec. 2018)Mrs Jan Mumford Chair, Consumer Advisory Panel Dr Adnan NagrialMedical Oncologist (joined Dec. 2018)Dr Andrew OarRadiation Oncologist (joined Dec. 2018) Associate Professor Nick Pavlakis Medical Oncologist Mr Charles PilgrimSurgeon (joined Dec. 2018)Professor Tim Price Medical Oncologist Dr Amitesh RoyMedical Oncologist (joined Dec. 2018)Professor Jaswinder SamraSurgeon (joined Dec. 2018) Dr Amy ShorthouseRadiation Oncologist (retired Dec. 2018) Professor John Simes Medical Oncologist Dr Katrin Sjoquist Medical Oncologist Ms Belinda Steer DietitianClinical Professor Nigel SpryRadiation Oncologist (retired Dec. 2018)

Lower GI Working Party Associate Professor Niall Tebbutt Chair, Medical Oncologist Professor Chris Karapetis Deputy Chair, Medical Oncologist Professor Stephen Ackland (joined June 2018)Medical OncologistDr Matthew Burge Medical Oncologist Dr Julie ChuRadiation Oncologist(joined June 2018)

Dr Connie Diakos Medical Oncologist(joined June 2018)Dr Jayesh Desai Medical Oncologist(retired June 2018)Professor Alexander EngelSurgeon(joined June 2018)Mr David Espinoza Statistician(joined June 2018)Mr Alexander Heriot Surgeon (retired June 2018)Mr Peter Hewett Surgeon (retired June 2018)Professor David Joseph Radiation Oncology (retired June 2018)Dr Cherry Koh Surgeon(joined June 2018)Dr Ben Markman Medical Oncologist (retired June 2018)Dr Paul McMurrick Surgeon (retired June 2018)Mr Robin Mitchell Deputy Chair, Consumer Advisory Panel Associate Professor Samuel Ngan Radiation Oncology (retired June 2018)Professor Rob Ramsay Translational Scientist(joined June 2018)Professor Bridget Robinson Medical Oncologist (retired June 2018)Professor Eva Segelov Medical Oncologist (retired June 2018)Associate Professor Jeremy Shapiro Medical Oncologist Dr Oliver Sieber Translational Scientist(joined June 2018)Associate Professor Jeanne Tie Medical Oncologist(retired June 2018)Dr Zee Zan Wong Medical Oncologist(joined June 2018)Professor Nik Zeps Biological Scientist

Pictured: Mr Jeff Cuff, Consumer Advisory Panel

Scientific Advisory Committee & Working Parties

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Reflecting on the 2018 financial year, it is clear that the AGITG continued its strategic focus to manage the current operations and build for the future. We were faced once again with many of the enduring, expected challenges and yet in light of this, 2018 saw some significant milestones in both operational and strategic objectives.

Implemented in 2015, the Innovation Fund is now providing new opportunities for scientific research and engaging AGITG members who have come forth with new ideas. The Fund supports emerging research concepts and enables greater opportunities to seek ongoing funding through government and institutional support. With seed funding for a pilot study, the MODULATE trial, for example, has now progressed and gained external funding.

International partnerships also provide vital support for our research. We have invested in our Annual Scientific Meeting and developed our Commonwealth Neuroendocrine Tumour Group (CommNETs) and Preceptorship programs so that the AGITG and its members have the opportunity to develop strong relationships across Australia and the world. Increasingly, multisite trials require the support of the international scientific and pharmaceutical community. In 2018, our programs have continued to grow with their support. Developing these partnerships and enhancing the global recognition of the AGITG and its members will be key to the success of our scientific trials into the future.

Likewise, managing our financial reserves in an increasingly volatile

investment market depends on our engagement with skilled professionals. The ongoing support from members of the AGITG Finance and Risk Management Committee, our CEO, and contracted accountants provides a strong platform to manage our financial affairs for the sustained success of the AGITG. Their continued support and advice on current and strategic investment decisions will enable the Board to further their strategic objectives with confidence on our financial position.

Increased engagement of our members in AGITG activities has been another significant factor in 2018. Their expertise ensures that the scientific management of our research is just as strong as our financial management. To strengthen our team, we employed our first Clinical Research Manager, Nisha Berthon-Jones who has already provided value in our various research activities and related programs. Her role extends to delivering on aspects of our strategic plan, which I look forward to reporting on in the future.

The Group has delivered the first year of its five-year Fundraising Strategic Plan. In this year, we have received more than $1 million dollars in donations, including our first bequest. Whilst the plan is still in its early stages, this level of support is encouraging for the future of this strategy. The development of our fundraising program is key to ensuring the diversity of funding for the operation of the organisation and for new trial initiatives now and in the future.

We continue to manage our assets to fund current and future research projects, to develop the marketing and fundraising program and to operate the business of the organisation in an effective and sustainable manner. The 2018

financial year has seen the net assets of the AGITG increase by $677,844. This increase has been a result of an operation deficit of $454,085, offset by donations received to our donation reserves of $1,131,929.

In recognising the achievements during the year and looking forward in our strategic plans, we express our appreciation of the support we’ve received from government, industry, and the various institutions who engage with the AGITG in our research activities. We extend our thanks to our members and our donors, and look forward to their ongoing support to enable us to continue our contribution to research in GI cancers.

Associate Professor Niall Tebbutt PhD MRCP FRACP Deputy Chair & Treasurer

Treasurer’s ReportIncreased engagement with our members and strengthening our international collaborations will build the capacity of the AGITG to improve outcomes for patients with GI cancer now and in the future.

Associate Professor Niall TebbuttDeputy Chair & Treasurer

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Income Statement Statement of profit or loss and other comprehensive income for the year ended 31 December 2018

2018 2017

$ $

Revenue 4,058,187 5,389,955

Other income 1,266,758 1,638,850

Administration/Infrastructure expense (517,254) (410,757)

Depreciation and amortisation expense (13,066) (64,101)

Trial and Site Costs (7,320) (5,259,554)

Scientific Events (3,690,077) (923,165)

Marketing/Fundraising costs (905,771) (473,937)

(Deficit) / Surplus before income tax (454,085) (102,709)

Income tax expense - -

(Deficit) / Surplus for the year (454,085) (102,709)

(Deficit) / Surplus for the year (454,085) (102,709)

Other comprehensive income after income tax

Other comprehensive income for the year, net of tax - -

Total comprehensive income for the year (454,085) (102,709)

Total comprehensive income attributable to members of the entity (454,085) (102,709)

These Financial pages are an extract from the audited accounts for the financial year ended 31 December 2018.

Balance SheetStatement of financial position as at 31 December 2018

2017 2017

$ $

Assets

CURRENT ASSETS

Cash and cash equivalents 4,031,020 3,924,432

Financial Assets 8,692,947 8,291,418

Trade and other receivables 627,917 1,231,774

Other assets 72,838 96,293

TOTAL CURRENT ASSETS 13,424,722 13,543,917

NON-CURRENT ASSETS

Property, plant and equipment - -

Intangible assets 81,745 71,210

TOTAL NON-CURRENT ASSETS 81,745 71,210

TOTAL ASSETS 13,506,467 13,615,127

Liabilities

CURRENT LIABILITIES

Trade and other payables 380,295 1,141,393

Other short-term liabilities 2,875,446 2,451,668

TOTAL CURRENT LIABILITIES 3,255,741 3,593,061

NON-CURRENT LIABILITIES

Long-term provisions 74,097 64,309

Other long-term liabilities 2,767,473 3,226,446

TOTAL NON-CURRENT LIABILITIES 2,841,570 3,290,755

TOTAL LIABILITIES 6,097,311 6,883,816

NET ASSETS 7,409,156 6,731,311

EQUITY

Reserves 4,503,214 3,471,181

Retained Earnings 2,905,942 3,260,130

TOTAL EQUITY 7,409,156 6,731,311

CONTINGENT LIABILITY - -

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Your Support Makes a Difference

Thanks to the support from our committed and passionate supporters, we continue to put patients at the centre of our research, saving and improving lives by accelerating the pace of discoveries that lead to cures.

Community support is critical for our dedicated group of research and health professionals to translate bold new ideas in to life-saving clinical trials that help people with GI cancer as quickly as possible. There have been a number of ways our supporters have made a difference to the lives of people diagnosed with GI cancer, their families and future generations.

DonationsThrough our regular appeals, donations have been received which enable us to conduct our clinical trials that lead to better health outcomes for patients. All donations, no matter what size, have contributed to trials initiated this past year. We also have continued to receive and grow the number of regular giving supporters – which provides us with the financial stability that allows us to plan for the future.

To make an online donation please visit www.gicancer.org.au/donate

The Gutsy ChallengeThis year we have had over 140 people participate in over 40 activities. This includes our Gutsy Overland Challenge in Tasmania,

our inaugural L’Etape cycling team, numerous running events and individuals who are undertaking personal challenges and a number of community fundraising activities – including the ‘Silly Hat for Matt’ Challenge – supporting Stomach Cancer, a Melbourne Movie Night, Penola Bowls Club fundraiser and the Dominic Colagiuri Cup Futsal Fundraiser, amongst others.

All funds raised through the Gutsy Challenge in 2018 went to the AGITG Innovation Fund, enabling our researchers to break new ground in areas that have not been studied previously. This research is a critical first step in the process of new clinical trials, as it enables members to accumulate the data and evidence required to then approach funding

bodies to progress to larger scale clinical trials.

To learn more see www.gicancer.org.au/gutsy

BequestsWe were privileged to receive a significant bequest from a munificent supporter during the year. Through leaving a gift in her Will, this supporter has left a meaningful legacy for future generations. There are many reasons why people choose to leave a bequest – most often it is a very personal decision. No matter whether the donation is large or small, bequests enable cutting edge research in to new treatments for patients diagnosed with GI Cancer beyond our lifetime.

To learn more see www.gicancer.org.au/yourwill or for a confidential conversation please call Nicky on 1300 666 769.

Honouring a Loved OneWe are very grateful for those family members who have lost someone

throughout the year and chosen to honour their loved one through In Memory donations, often collected during the funeral in lieu of flowers. These donations create something positive by supporting innovative research for improved outcomes for future generations.

To arrange for personalised In Memory donation cards or for more information please contact Alaine on 1300 666 769.

Living Room Community EventsIn May 2018 we held our annual Living Room Event at the Chris O’Brien LifeHouse in Sydney and in November a Living Room Series event in Melbourne to coincide with Pancreatic Cancer Awareness Month. Our Sydney supporters were invited to hear about the gastro-intestinal cancer research presented at the American Society of Oncology (ASCO) from leading researchers and medical oncologists, Professor Chris Karapetis and Dr Katrin Sjoquist. Our Melbourne supporters were invited

to hear Associate Professor Niall Tebbutt, Associate Professor Lara Lipton, Dr Belinda Lee and pancreatic cancer survivor Linda Wilson address different aspects of pancreatic cancer treatment and research.

VolunteersThroughout the year we have been supported by a number of skilled volunteers who have each made a real difference to our ability to fund our clinical trials. In addition, supporters including cancer survivors and their families have generously come forward to share their stories, which assists us to raise awareness of the often hidden GI cancers and promote the difference our clinical trials are making to the lives of patients.

Community support is vital in funding GI Cancer clinical trials research now and in to the future. For more information on how to get involved, please contact us on 1300 666 769 or visit www.gicancer.org.au/getinvolved

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Thank you to our members who volunteer their time, expertise and commitment, to our sponsors who support our activities financially, and to our donors who give generously to continue to improve the outcomes of people with GI cancer. Your support and dedication is vital to our work in delivering the best practice medical treatment for patients.

GI Cancer Institute Sponsors

Platinum Sponsors

Gold Sponsor

Thank You

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Australasian Gastro-Intestinal Trials Group & GI Cancer Institute · ABN 34 093 854 267Locked Bag M250, Camperdown NSW 2050 · T. 1300 666 769 · F. 02 9562 5348