Title: Radiation Therapy Trials Quality Assurance:
1- Radiation Therapy Trials - Quality Assurance
-
- patient safety
- adherence to protocol constraints
- uniformity of patient treatments
- efficient review of patient data
2CTEP supported CLINICAL TRIAL QA CENTERS RTOG,
Philadelphia (RTOG) QARC, Providence (COG,
CALGB, SWOG, ECOG, ACOSOG, - - - ) RPC, MD
Anderson (NSABP, GOG and physical dose QA for ALL
groups)
Review item chart images study chairs
archives
Conventional Post Tx Few hard copy- largely
2D Travel to QA center Hard copy- difficult
searches
Advanced tech trials Real-time and pre-Tx Gbytes
of digital multi modality Remote review by
internet Digital full datasets
ATC cooperative agreement developmental ITC,
RCET implementation RTOG, QARC, RPC
3RPC IMRT Phantom Test
- RPC tests ability of each institution to deliver
IMRT by asking facility to - Scan RPC phantom (CT, MRI, etc.)
- Generate an IMRT plan according to defined
protocol - Deliver treatment to phantom
- Return phantom and dosimeters to RPC for
evaluation. - Submit digital planning data to the ITC
- RPC uses ATC Remote Review Tool to analyze data
4Phantom Results Comparison between institutions
plan and delivered dose. Criteria for agreement
7 or 4 mm DTA
30 of institutions failed HN phantom on the
first attempt
5RTOG 0022 Dry-Run TestPHASE I/II STUDY OF
CONFORMAL AND INTENSITY MODULATED IRRADIATION FOR
OROPHARYNGEAL CANCER
- Of 18 Institutions that were ultimately
credentialed - Number of submissions it took to meet
credentialing guidelines - 6 institutions required 1 submission
- 9 institutions required 2 submissions
- 3 institutions required 3 submissions
- ( these were large academic centers)
6NCI IMRT PROTOCOL REQUIREMENTS
- 2002 guidelines for IMRT use in clinical trials
were established to ensure the safety and
comparability of these radiation treatments. - 2005 NCI announced revisions in these guidelines
allowing use of IMRT for intra-thoracic
treatments. - 2006 specific guidelines for use of IMRT for
intra-thoracic treatment protocols with
respiratory gating
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9- ISSUES (some) CONCERNING
- PROTON THERAPY (multi-institutional trails)
1) No national standard for proton calibration
2) Two different calibration protocols in use
among US facilities
3) RPC still developing methods for remote review
of dosimetry ( TLD?)
4) RPC still developing a proton compatible
phantom
5) ATC still verifying compatibility of proton Tx
planning computers
6) Proton dose computation algorithms standards
at the QA centers in addition to secondary
neutron production modeling
7) Protocol specific field placement
verification, critical nature of heterogeneity
corrections, GTV margins re SOBP distal edge
dosimetry and lateral penumbra,