1. SBRT trial QA IROC GHG meeting at ESTRO May, 2017

2. 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

3. 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)

4. 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

5. 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%

6. 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

7. 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

8. 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)

9. 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

10. 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

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

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

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

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

15. 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

16. 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

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

18. End