1. UK Radiotherapy Trials QA (RTTAQ) Group
SBRT trial QA programmes
GHG meeting - ESTRO May 2017

2. QA Programme: NHSE CtE (England only) (NHS England Commissioning through Evaluation)
QA component
Service Specification
Standards for the provision SABR including site specific information: indications for treatment, dose prescription, TV and OAR delineation, follow up
Technical Guidance
Guidance on minimum technical standards: immobilisation, imaging, contouring, planning
Pre-accrual QA
Facility Questionnaire
Equipment and technique (all anatomical sites)
Process document
Specific technique information per anatomical site
Outlining Benchmark Cases
5 cases for each: Lung, Spine, Liver, Pelvic Node, Adrenal. Completed per clinician
Planning Benchmark Cases
5 cases for each: Lung, Spine, Liver, Pelvic Node, Adrenal. Completed per centre and per delivery modality
Lung Dosimetry Audit
UK SABR consortium Lung audit
During accrual QA
Prospective ICR
At least 1st patient for each treatment site per centre and per clinician (3 for re-irradiation cases)
Retrospective ICR
All data
Spinal Dosimetry Audit
All centres treating oligometastases

3. Collaborative work: Trialists, RTTQA and UK SABR consortium
UK Consensus on Normal Tissue Dose Constraints for Stereotactic Radiotherapy
Collaborative work: Trialists, RTTQA and UK SABR consortium
Adopted by the NHSE CtE and in clinical use for current and future SABR trials
Submitted for publication: UK Consensus on Normal Tissue Dose Constraints for Stereotactic Radiotherapy
Hanna GG, Patel R, Aitken A, et al UK stereotactic Ablative Radiotherapy trials normal tissue dose constraints tolerance consensus. 2016; Radiother. Oncol. 119:1; S191

4. Current and future trials
Summary
CLOSED
SABRTooth
PH III SABR vs surgery in peripheral Stage I NSCLC
UK only
RECRUITING
ABC-07
PH II chemotherapy +/- SABR in locally advanced biliary tract cancers
SARON
PH III SABR for Oligometastatic NSCLC
Early discussions EORTC
CORE
PH II/III Addition of SABR to standard therapy for oligometastatic disease
Intergroup study TROG
(Appendix to protocol accepted - dose schedules)
PACE
Prostate
International recruitment
IN SET-UP
HALT
PH II/III Ablative Radiotherapy for Oligo-Progressive Disease (OPD) in Oncogene Addicted Lung Tumours
Intergroup study EORTC

5. Trial QA activities Activity SABRTooth ABC-07 SARON CORE HALT
Preliminary
Protocol review 
RTTQA advise on QA required
RT guidelines 
RTTQA input to specific treatment delivery details
Pre-accrual FQ
 CtE PD
IGRT
4DCT benchmark cases (lung and liver)
Benchmarks
SRS brain
Lung audit
Or equivalent audit e.g. ArcCheck
During Accrual
Prospective ICR
1st patient (per # schedule)
All patients
1st patient
Retrospective ICR
Plan Assessment Form
Data collection
All
Spinal audit

6. Lung audit 37 centres audited
As required for trial /commissioning programme
Single machine, single energy
Motion management not assessed
Postal audit using CIRS Model 002LFC IMRT thorax phantom
EBT3 GafChromic film - planar dosimetry
Alanine dosimeters – dose at target volume centre
CT dataset of phantom with pre-defined volumes (ITV) sent to centres for planning
Alanine results showed planned and delivered doses were within ±3.0% for 34/37 SABR plans

7. Spinal audit SABR Spine dosimetry audit Dosimetry
CIRS E2E SBRT phantom
Dosimetry
Axial GafChromic Film (yellow)
Alanine and MicroDiamond detectors (orange)
Measurement in bone CTV (red) and water equivalent cord

8. Outlining benchmark Same cases for all centres
Reviewed against a standard by study CI +/- TMG members
Drop down menus:
No variation (per-protocol)
Acceptable (variation)
Unacceptable (variation)

9. Planning benchmark Same cases for all centres
Reviewed against protocol prescription and mandatory and optimal dose constraints by RTTQA

10. Individual case review
Prospective:
Turnaround time 48-72hrs
Outlines submitted for review prior to plan
Amendments to outlines and plan implemented and re-reviewed before treatment
Pressure to avoid delays to planned treatment start date
Report format same as benchmark case review
Retrospective:
Timely retrospective - within first week of treatment
Standard retrospective - during trial
No direct feedback to centres

11. What has worked …and what hasn’t!
Audit cost and familiarity (borrowing local phantoms)
Consistency of treatment across all centres
Streamlining - faster trial QA approval
Positive feedback from majority of centres
Enabled inexperienced centres to clinically implement SABR with support
Learning experience for centres with similar equipment
Large data set
An overall view of what is achievable with specific equipment combinations
Facilitate future development of plan metrics
Audit logistics
Borrowing phantoms
Coordination of audit aspects from multiple centres
Audit limitation
Non standard local plan, harder to provide feedback
No movement
Workload
Many treatment sites
Underestimated number of clinicians
Huge workload for individual centres and RTTQA
Planning aspects more challenging with higher failure rate compared to outlining
Lung case relatively easy as well established.
Liver case hardest to set up – motion management issues. Liver contouring high failure rate.

12. Preliminary discussions
Collaborative work
TRIAL
Summary
QA GROUP
Comment
LUNG-TEC
Stereotactic Body Radiotherapy (SBRT) of Inoperable Centrally Located NSCLC
EORTC
Dosimetry audit only
EPENDYMOMA II
International Clinical Program for Diagnosis and Treatment of Children With Ependymoma
QUARTET
PNET 5
International Society of Paediatric Oncology (SIOP) PNET 5 Medulloblastoma
ROAM
Radiation versus observation following surgical resection of atypical meningioma
UK QA
HALT
Ablative Radiotherapy for Oligo-Progressive Disease (OPD) in Oncogene Addicted Lung Tumours
Standardise QA
PATHOS/BEST OF
Post-operative Adjuvant Treatment for oropharyngeal HPV-positive Tumours
SARON
Stereotactic Ablative Radiotherapy for Oligometastatic Non-small Cell Lung Cancer
Preliminary discussions
STAR-TREC
Watchful waiting or transanal surgery following CRT versus total mesorectal excision for early rectal cancer
Denmark & Netherlands
CORE
Addition of SBRT to standard therapy for oligometastatic disease
TROG
RAIDER
Study of Tumour Focused Radiotherapy for Bladder Cancer
PLATO
PLATO - Personalising anal cancer radiotherapy dose
INPACT
An international study looking at the treatment of inguinal lymph glands in cancer of the penis
IROC

13. CORE - International QA
Document / Process
Origin
Comment
Protocol UK
Single document with TROG appendix
RT Guidelines
Facility Questionnaire
UK and TROG
Each group utilises its own FQ
Additional trials specific questions may be required
Dosimetry Audit
TROG VESPA audit (appropriate anatomical site to be requested) accepted
ACDS annual output
Other TROG audits Chisel, Nivorad
Benchmark Cases
UK cases
TROG centres access cases through CQMS platform
TROG centres submit data through CQMS platform
First few cases central RTTQA and TROG review to ensure accuracy and consistency of review
Subsequent cases each country responsible for own benchmark review
Ongoing audit of selected patients to ensure continued consistency
Individual Case Review
Prospective
Subsequent cases each country responsible for their own prospective ICR review
Data Collection
TROG collect all Australasian data via CQMS
Data transfer to UK
Data transfer from TROG to UK. Options:
Mount Vernon Cancer Centre (MVCC) Secure FTP
National Welsh Informatics Service (NWIS)
UK has multiple clinical trials units
All hold a portfolio of trials
RTTQA group have to work with a number of trials units – no central organisation similar to the EORTC