Radiation Therapy Trials - Quality Assurance:

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• Radiation Therapy Trials - Quality Assurance
• patient safety
• adherence to protocol constraints
• uniformity of patient treatments
• efficient review of patient data

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CTEP 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
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RPC 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

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Phantom Results Comparison between institutions
plan and delivered dose. Criteria for agreement
7 or 4 mm DTA
Phantom HN Prostate Thorax Liver
Irradiations 254 73 30 6
Pass 179 55 17 3
Fail 71 9 7 1
Under analysis or at institution 30 6 6 1
Year introduced 2001 Spring 2004 Spring 2004 Spring 2005
30 of institutions failed HN phantom on the
first attempt
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RTOG 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)

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NCI 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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• 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,