How does RTQA impact on clinical Outcome...Objectives •To understand why RTQA is important in/for...
35
How does RTQA impact on clinical Outcome Prof. Dr.med. Damien Charles Weber Paul Scherrer Institut USZ, University of Zürich, Switzerland Inselspital-Hôpital de L’Ile, University of Bern, Switzerland Co Chair, RTQA Strategic, ROG
Transcript of How does RTQA impact on clinical Outcome...Objectives •To understand why RTQA is important in/for...
How does RTQA impact on clinical Outcome
Prof. Dr.med. Damien Charles Weber Paul Scherrer Institut
USZ, University of Zürich, Switzerland
Inselspital-Hôpital de L’Ile, University of Bern, Switzerland
Co Chair, RTQA Strategic, ROG
Objectives • To understand why RTQA is important in/for a
intergroup study/trial
• What are the levels of RTQA
• What is the structure of the RTQA group/platform within EORTC
• To see the staffing and equipment of European Centers
• To acknowledge the ‘quality’ of RT in Europe (BOA)
• Conclusions
2
3
4
• Tissue contamination • Storage containers • Containers filling • Room temperature • Malfunctioning equipment • …. Started in
2007 University of Minnesota-
Veterinary Diagnostic Laboratory in St Paul
5
1977 RTOG initiation of QA program
Retrospective analysis of RTQA showing 19% rate of major deviations (37/198)
Composed of: 1) On study review (First
week of RT) 2) Retrospective review
6
Eur J Cancer 1993;29A(2):181-184
Assess Quality through • Assessment of structure
(Equipment and Work force) • Measurement of process • Patients’ outcome
7
Specific consideration of RTQA for clinical prospective trials
EORTC 22043 BC
Example of Benchmark Case (BC):
Parotid
3D-CRT IMRT
Example of IMRT:
Parotid
10
26081 – Major # 3 ICR evaluations
• Major # 3: Wrong protocol used (declared “no boost = European way”, used “boost = American way”).
11
12
13
The ‘quality’ of RT developed in (EORTC) trials should be guaranteed, so as not to corrupt the endpoints of the trial.
14
Messages:
Non adherence to protocol specified RT is associated with potential reduced OS, LC and increased toxicity
15
Examples of trials where the poor quality of RT did indeed corrupt the primary end point: The Head Start trial.
16
17
18
19
20
21
22
Facility Questionnaire (FQ) External Reference Dosimetry Audit (ERDA)
Dummy Run (DR)
Limited Individual Case Review (ICR)
Extensive Individual Case Review (ICR)
Complex Dosimetry Check
1
2
3
4
5
23
Facility Questionnaire (FQ) External Reference Dosimetry Audit (ERDA)
Results from Facility Questionnaire
• One hundred and fifty-six centers from 22 countries completed a validated FQ.
• Over this 6 year period the summed average number of cases treated in these centers increased from 2,011 to 2,377.
24
0
5
10
15
20
25
30
35
40
45
<=1000 1001-1500 1501-2000 2001-2500 2501-3000 3001-3500 >3500
Pe
rce
nta
ge o
f To
tal
Ce
nte
rs
Number of cases treated per year
1992
2007
2013
Results from Facility Questionnaire
25
0%
5%
10%
15%
20%
25%
30%
35%
40%
<=200 201-250 251-300 301-350 >350
Pe
rce
nta
ge o
f To
tal C
en
ters
Number of cases treated per radiation oncologist per year
1992
2007
2013
Resu
lts from
Facility Qu
estio
nn
aire
26
2013 (156 Centers)
Mean Median Range SD
No cases treated/year 2381.4 1938 (350-12000) 1671.3
No FTE Rad Oncs per dept 10.8 8 (1-41) 7.9
No FTE Physicists per dept 7.4 6 (1-35) 5.3
No RTTs per dept 36.1 23 (3-227) 32.9
No cases per RO 243.2 232 (78-617) 94.7
No cases per Physicists 354.3 320 (114-870) 154.3
No cases per RTT 85.7 77 (7-350) 48.1
No RTT per treatment unit 2.9 3 (2-6) 0.9
2007 (98 Centers)
Mean Median Range SD
No cases treated/year 2016.0 1696 (470-7300) 1272.3
No FTE Rad Oncs per dept 8.5 7 (2-26) 5.3
No FTE Physicists per dept 5.2 4 (1-22) 3.4
No RTTs per dept 26.1 17 (3-120) 22.2
No cases per RO 258.0 248 (99-480) 84.5
No cases per Physicists 426.0 413 (124-827) 142.8
No cases per RTT 107.0 86 (34-734) 96.0
No RTT per treatment unit 2.4 2 (1-5) 1.0
1992 (50 Centers)
Mean Median Range SD
No cases treated/year 1452.0 (300-3600) 783.0
No FTE Rad Oncs per dept 6.0 (1-22)
No FTE Physicists per dept (1-8)
No RTTs per dept
No cases per RO 316.0 263 (60-1243)
No cases per Physicists 464.0 370 (166-1052 )
No cases per RTT 131.0 100 (36- 420)
No RTT per treatment unit 2.8
Resu
lts from
Facility Q
uestio
nn
aire
27
2013 (156 Centers)
Mean Median Range SD
No. Megavoltage units 5.3 4 (1-16) 3.0
No. cases per Unit per year 468.6 450 (175-1733) 183.6
No. cases per simulator/year 1622.9 1542 (350-7000) 1260.0
% centers with dedicated CT Sim 92
% centres with IMRT capability 94
% centres with SBRT capability 65
2007 (98 centers)
Mean Median Range SD
No. Megavoltage units 3.9 3 (1-12) 2.1
No. cases per Unit per year 488.0 456 (192-1000) 149.7
No. cases per simulator/year 1117.0 1038 (251-2750) 489.1
% centers with dedicated CT Sim 86
% centres with IMRT capability 79
% centres with SBRT capability 54
1992 (50 centers)
Mean Median Range
No. Megavoltage units 2.6
No. cases per Unit per year 506.0 (234-1033)
No. cases per simulator/year 1192.0 (300-2341)
% centers with dedicated CT Sim 22
Conclusions (FQ)
• The standards set by the EORTC-ROG are met by a continually improving number of centers, particularly in regard to staffing levels, treatment planning and machine use, helping to safeguard use of advanced technologies in EORTC-ROG clinical trials.
• Numbers of patients treated by ROs and RTTs decreasing
• Numbers of patients planned by Medical physicists decreasing
• EORTC centers are treating more patients annually
• Improving capacity of IMRT delivery and CT simulations
28
Results of BOA • A total of 465 BOA-reports, performed over a time period of
8.5 years (May 2005 until December 2013) were assessed.
• These reports were made for 279 institutions, from 33 countries, which provided at least one BOA-report to EORTC for inclusion in a clinical trial involving RT.
• The results of 3171 beams , delivered by 755 different treatment units were assessed. This included 18 results for Co-60 beams, 1790 (56%) for photon beams (of which 11 ‘stereotactic radiosurgery dosimetry’) and 1363 (44%) for electron beams.
29
Results of BOA
30
Results of BOA
31
• On average 4 beams (range, 1-65) and 2 treatment units (range, 1-17) were tested during an audit.
• Most of the audits were performed by IROC, EQUAL and different auditing bodies which can be brought back to the common denominator of national organizations.
Local national bodies ( like
PTW Freiburg (Germany),
SSRMP (Switzerland)
etc.) 38%
IROC (RPC) 35%
Equal 19%
IAEA 4%
ARPANSA
3% AAPM
1%
Results of BOA
32
• Fourteen beams (0.4%), of which 10 electron and 4 photon beams, were out of the range of acceptance of 5%, 8.5% were within the non-optimal range (3-5%) of acceptance and 91.1% of the beams were within the optimal limit of < 3%.
0
100
200
300
400
photons Electrons
Measure of discordance between stated and measured dose (%)
Nu
mb
er o
f b
eam
s
Results of BOA
33
0
50
100
150
200
250
1-3machine(s)
4-8machines
9-17machines
Nu
mb
er o
f B
OA
-re
po
rts
0
20
40
60
80
100
120
Nu
mb
er o
f B
OA
-rep
ort
s
Results of BOA Conclusions:
• Our analysis shows that the majority (91.9%) of center present beam output variations within the 3% tolerance cutoff.
• Only 0.4% of all beam results were found discrepant in respect to a ± 5% level. Although already over 90% of the beams are within the optimal level of agreement (≤ 3%), ideally these results should be optimized. Unfortunately, no temporal trend for improvement has been observed in our study.
34
THANK YOU
Questions?
