STAR_TREC: Can we Save the rectum, by watchful waiting or TransAnal surgery following (Chemo)Radiotheraphy versus Total mesorectal excision for early REctal Cancer?
Trial summary:
STAR-TREC is an international, multi-centre, open-label, rolling phase II/III trial with a partially randomised patient preference design. Patients will choose organ preservation or standard surgery. Those who prefer organ preservation will be randomised 1:1 between (i) organ preservation with mesorectal Chemoradiotherapy (CRT) versus (ii) organ preservation with mesorectal Short Course Radiotherapy (SCRT). Those who prefer standard surgery or have no preference will undergo standard Total Mesorectal Excision (TME) surgery without neoadjuvant radiotherapy treatment.
380 patients will be randomised internationally to the organ preservation arms (CRT and SCRT), including 80 patients recruited during phase II and 300 during phase III. Around 120 patients will be recruited to the standard surgery comparator arm, including 40 during phase II and around 80 during phase III.
RT QA summary:
All QA activity will be streamlined with previous trial QA, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss.
| QA Process | QA Activity | Required for Trial | Additional Details |
|---|---|---|---|
| Pre-Accrual | Facility Questionnaire |  | Including Process Document |
| Outlining Benchmark Case | | 1 case | |
| Planning Benchmark Case | | 1 case | |
| Dummy Run | |||
| During Accrual | Individual Case Review | | |
| Data collection | | ||
| Dosimetry | | ||
| QA Streamlining | | APHRODITE |
RTTQA contact: STAR-TReC.RTTQA@wales.nhs.uk
Chief investigator: Simon Bach S.P.Bach@bham.ac.uk
RT Lead: Mark Teo mark.teo@nhs.net
Sponsor: University of Birmingham (STAR-TREC@Trials.bham.ac.uk)
Funder: CRUK