How does RTQA impact on clinical Outcome Prof. Dr.med. Damien - - PowerPoint PPT Presentation

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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5 10 15 20 25 30 35 40 45

<=1000 1001-1500 1501-2000 2001-2500 2501-3000 3001-3500 >3500

Percentage of Total Centers Number of cases treated per year 1992 2007 2013

Results from Facility Questionnaire

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0% 5% 10% 15% 20% 25% 30% 35% 40% <=200 201-250 251-300 301-350 >350 Percentage of Total Centers Number of cases treated per radiation oncologist per year 1992 2007 2013

Results from Facility Questionnaire

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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

Results from Facility Questionnaire

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

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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%

• f the beams were within the optimal limit of < 3%.

100 200 300 400 photons Electrons Measure of discordance between stated and measured dose (%)

Number of beams

Results of BOA

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50 100 150 200 250 1-3 machine(s) 4-8 machines 9-17 machines

Number of BOA -reports

20 40 60 80 100 120

Number of BOA-reports

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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THANK YOU

Questions?