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

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: ATC cooperative agreement developmental: ITC, RCET implementation: RTOG, QARC, RPC 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

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 TLDs

Phantom Results Comparison between institution’s plan and delivered dose. Criteria for agreement: 7% or 4 mm DTA * 30% of institutions failed H&N phantom on the first attempt PhantomH&NProstateThoraxLiver Irradiations Pass 179*55173 Fail Under analysis or at institution Year introduced2001Spring 2004 Spring 2005

RTOG 0022 Dry-Run Test PHASE 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)

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

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,