SBRT trial QA IROC GHG meeting at ESTRO May, 2017

Current trials LU-002: Phase III chemo ±SBRT in Lung BR-001: Phase I safe SBRT tx of multiple mets BR-002: Phase III chemo ±SBRT for oligometastatic disease RTOG 0631: Phase III Spine SBRT vs conventional COG AEWS-1221: Phase II SBRT for bone mets Allows SBRT for bone mets (chemo trial) COG ARST-1431: Phase III Rhabdomyosarcoma

Trial QA activities LU-002 BR-001 BR-002 RTOG 0631 1431/1221 Pre-clinical Protocol review Credentialing Output check Soft-tissue IGRT Soft-tissue & boney IGRT Boney IGRT Lung phantom Spine phantom Benchmark Case Review 1 pre-tx review Pre/on-tx for primary (all) All post-tx review Post-tx for mets (all)

Protocol review Is credentialing and trial QA appropriate Some PIs involve us from the get-go Sometimes the PI has just copied a previous trial Not reasonable QA Not correct links Is the protocol clear Clarification can help avoid confusion Not generally changing protocol

Annual Output Checks Everyone does this, not specific to a protocol Annually: All photon beams Every other electron beam OSLD: 1.6% uncertainty 5% tolerance 0.3% of results out of tolerance Half of last year, statistical expectations is 0.06%

IGRT credentialing Boney or soft-tissue Questionnaire tolerance for re-imaging, process for alignment Submit prior patient & plan with 2 days of setup Evaluate image quality IGRT process Qualitative Rejection rare

Phantom End-to-end test Must pass once (grandfathered for future trials) Phantom Spine Lung Irradiations 343 1166 Pass 267 (78%) 971 (83%) Fail 76 195 Criteria 5%/3mm 5%/5mm

Phantoms Clearly lots of large problems Teasing out the underlying problems is hard End-to-end Beam model Motion management CT calibration curve Clinical management (couch)

Case/benchmark reviews Similar patient from institution Single CT dataset (e.g., patient selected by PI) Pre-treatment review Must be reviewed before start of tx Post-treatment review Case retrospectively reviewed for compliance

Case/benchmark reviews Clinical review Conducted by Radiation Oncologists, often study PI and/or study review team Field borders/target definition Dosimetry review Conducted by IROC Doses per protocol Timing and fractionation per protocol Cases submitted are all opened and assessed in MIM for uniform comparison platform

Clinical review 1 = per 2 = minor 3 = major 4 = N/A

Clinical review 1 = per 2 = minor 3 = major 4 = N/A

Dosimetry review 1 = per 2 = minor 3 = major 4 = N/A

Dosimetry review 1 = per 2 = minor 3 = major 4 = N/A

Benchmark Dummy case to show ability to plan per protocol Pros: Cons: Identifies many problems (15% major dev.) Confirms that institution has read protocol Cons: Ties up credentialing resources for institutions that often do not end up participating Moving away from Benchmarks

Pre-treatment review Usually done for first patient from institution Sometimes first three patients Pros Identifies issues (25% major dev.) Forces protocol compliance Cons Stressful – clinical and dosimetry review in 3 days Delays – 3 day delay in treating patient. More if there are modifications required and the case must be changed and re-reviewed

Post-treatment review All protocol patients undergo review 10% major deviation rate Must identify for statistical analysis

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