How does RTQA impact on clinical Outcome...Objectives •To understand why RTQA is important in/for...
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
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• Tissue contamination • Storage containers • Containers filling • Room temperature • Malfunctioning equipment • …. Started in
2007 University of Minnesota-
Veterinary Diagnostic Laboratory in St Paul
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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
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Eur J Cancer 1993;29A(2):181-184
Assess Quality through • Assessment of structure
(Equipment and Work force) • Measurement of process • Patients’ outcome
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Specific consideration of RTQA for clinical prospective trials
EORTC 22043 BC
Example of Benchmark Case (BC):
Parotid
3D-CRT IMRT
Example of IMRT:
Parotid
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26081 – Major # 3 ICR evaluations
• Major # 3: Wrong protocol used (declared “no boost = European way”, used “boost = American way”).
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The ‘quality’ of RT developed in (EORTC) trials should be guaranteed, so as not to corrupt the endpoints of the trial.
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Messages:
Non adherence to protocol specified RT is associated with potential reduced OS, LC and increased toxicity
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Examples of trials where the poor quality of RT did indeed corrupt the primary end point: The Head Start trial.
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Facility Questionnaire (FQ) External Reference Dosimetry Audit (ERDA)
Dummy Run (DR)
Limited Individual Case Review (ICR)
Extensive Individual Case Review (ICR)
Complex Dosimetry Check
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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.
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Number of cases treated per radiation oncologist per year
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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
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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
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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.
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Results of BOA
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Results of BOA
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• 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
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• 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%.
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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.
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