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MRC SUPREMO(BIG 2-04) 

  Selective Use of Postoperative Radiotherapy aftEr MastectOmy

Phase III randomised trial of chest wall RT in intermediate- risk breast cancer

Kunkler I, Canney P, Price A, Anderson N, Dixon J, Sainsbury R, Aird E, Thomas G,Bowman A, Thomas J, Bartlett J, Devine I, Denvir

M, McDonagh T, Russell N, Cairns J, Boon Chua, Karlsson P, Northridge D, van Tienhoven G, Velikova G,Walker A, Macdonald E

 

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• Protocol V29• Eligibility Guide – Non Neo-adjuvant & Neo-adjuvant• Informed Consent Procedures• SAE Guidelines• Supremo Team• Recruitment

Agenda

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• Implemented on the 14th February 2011• 108 out of 157 sites confirmed approval for V29

UK: 104 out of 117 International: 4 out of 9 (5 China sites will continue to

work to V27)EORTC: 0 out of 31. New protocol approved in April

2011 and is due to be implemented by Summer 2011.

Protocol V29

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• Patients should have a verbal explanation of the trial and be given most recent MREC-approved Patient Information Sheet (PIS) for the main SUPREMO trial/TRANS-SUPREMO and Quality of Life/Health Economics sub-studies (version 29)

Patient Consent Procedures 1

Patient Information

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• Consent forms must be printed on hospital headed paper & accompanied by centre’s standard radiotherapy information sheets

• All participating patients must sign the most recent version of consent forms (separate consent forms for Main trial/TRANS-SUPREMO, Quality of Life/Health Economics substudies).

• Patients must initial, not tick boxes

• PI to countersign forms, but PI can delegate responsibility as appropriate (must be clearly documented in delegation log).

• No trial procedures can be performed prior to the patient giving informed consent.

Patient Consent Procedures 2

Consent Form Completion

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4 copies of signed consent forms required

• Original copy should be kept in site folder

• Copy given to patient

• Copy sent to ISD CCTT

• Copy kept in patient hospital notes

Patient Consent Procedures 3

Consent Form Copies

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A SAE is defined as an untoward occurrence that:

• Results in death

• Is life threatening

• Requires hospitalisation or prolongation of existing hospitalisation

• Results in persistent disability or incapacity

• Is a congenital anomaly/birth defect

• Is otherwise considered medically significant by the investigator

Serious Adverse Events 1

SAE Definition

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For SUPREMO patients receiving radiotherapy the potential expected adverse events/reactions include:

• Skin reactions leading to chest wall tenderness and itching

• Chest wall pain

• Pneumonitis (inflammation of the lung) causing shortness of breath

• Osteitis (inflammation of the ribs) causing the ribs to fracture

• Late cardiac damage

If any of the above expected reactions fall under the definition of SAE they should be listed on SAE/SUSARs form

Serious Adverse Events 2

Expected Radiotherapy SAEs

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Serious Adverse Events 3

Chemotherapy SAEs

Chemotherapy related SAEs that require reporting

Chemotherapy related SAEs that do not require reporting on SAE/ SUSAR form (unless they impact on delivery of the randomised treatment)

1. Wound infections2. Necrosis of the mastectomy skin

flaps3. Any cardiac event4. Development of any other serious

medical condition between date of consent and planned start of radiotherapy (or equivalent period for those patients randomised to not receive radiotherapy)

Hospitalisation due to:1. Neutropenia2. Febrile neutropenia3. Diarrhoea4. Infections, including those to Hickman

line, catheter.5. Pyrexia6. Sore throat7. Nausea or vomiting8. Cellulitis

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At the centre:• Use SAE/SUSAR form to report all SAEs (even if the SAE is chemotherapy related)• Fax copy to ISD Trials Unit within 24 hours (from site staff becoming aware)• Do not delay because of missing information and/or signatures• Local PI to assess whether unexpected, severity and/or related to radiotherapy• Provide missing information (and outcome information) as soon as it is known

Serious Adverse Events 4

Reporting

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ISD Trials Unit will:

• Allocate an SAE number

• Forward initial report to CI immediately if local PI assesses event as unexpected

• Advise the PI if SAE is evaluated as a SUSAR

• Comply with NRES guidelines on reporting of SAEs

• Report all SAEs to DMEC/MREC on an annual basis

Serious Adverse Events 5

Processing

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SUPREMO Team

Eve Macdonald (eve.macdonald@nhs.net) Senior Trial Coordinator

Julian Lipscombe (jlipscombe@nhs.net) Trial CoordinatorLeigh Fell (leigh.fell@nhs.net) Trial Coordinator

Ann Moncrieff (ann.moncrieff@nhs.net) Data Manager

ISD Cancer Clinical Trials Team Edinburgh

nss.isdsupremo@nhs.net

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• Randomisation service

• Advice on protocol and eligibility

• Investigator Site Files (ISFs)

• Regular newsflashes & website reports (

www.supremo-trial.com)

• 10% Source data monitoring

Trial Co-ordination Provided by ISD Trials Unit

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Recruitment to date (as of 30/5/11)

• Main trial 1078

• TRANS SUPREMO 850• Quality of Life 611• Cardiac substudy 53• Health Economics 41

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Recruitment to date (cont.)SUPREMO Accrual v Sites Open

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Predicted Accrual

Actual Accrual

Sites Open

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Thank you for your time.

Questions?

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ISD CANCER CLINICAL TRIALS

TEAM