Introduction Total mesorectal excision (TME) is the highly effective standard treatment for rectal cancer but is associated with significant morbidity and may be overtreatment for low-risk cancers. This study is designed to determine the feasibility of international recruitment in a study comparing organ-saving approaches versus standard TME surgery.
Methods and analysis STAR-TREC trial is a multicentre international randomised, three-arm parallel, phase II feasibility study in patients with biopsy-proven adenocarcinoma of the rectum. The trial is coordinated from Birmingham, UK with national hubs in Radboudumc (the Netherlands) and Odense University Hospital Svendborg UMC (Denmark). Patients with rectal cancer, staged by CT and MRI as ≤cT3b (up to 5 mm of extramural spread) N0 M0 can be included. Patients will be randomised to either standard TME surgery (control), organ-saving treatment using long-course concurrent chemoradiation or organ-saving treatment using short-course radiotherapy. For patients treated with an organ-saving strategy, clinical response to (chemo)radiotherapy determines the next treatment step. An active surveillance regime will be performed in the case of a complete clinical regression. In the case of incomplete clinical regression, patients will proceed to local excision using an optimised platform such as transanal endoscopic microsurgery or other transanal techniques (eg, transanal endoscopic operation or transanal minimally invasive surgery). The primary endpoint of this phase II study is to demonstrate sufficient international recruitment in order to sustain a phase III study incorporating pelvic failure as the primary endpoint. Success in phase II is defined as randomisation of at least four cases per month internationally in year 1, rising to at least six cases per month internationally during year 2.
Ethics and dissemination The medical ethical committees of all the participating countries have approved the study protocol. Results of the primary and secondary endpoints will be submitted for publication in peer-reviewed journals.
Trial registration number ISRCTN14240288, 20 October 2016. NCT02945566; Pre-results, October 2016.
- rectal cancer
- watchful waiting
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Contributors All collaborators made substantial contributions to the design of the study and/or were involved in drafting the manuscript. All collaborators read and approved the final manuscript.
Funding STAR-TREC is an international study, separately funded in each participating country. In the UK, this work was supported by Cancer Research UK (C41557/A19393), in the Netherlands by the Dutch Cancer Society (KWF KUN 2014-7448) and in Denmark by the Danish Cancer Society (R100-A6747). Contact information of Trial sponsor: Birmingham Clinical Trials Unit (BCTU), Institute of Applied Health Research, College of Medical and Dental Sciences, Public Health Building, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK. Phone: 0121 415 9104; email: STAR-TREC@trials.bham.ac.uk.
Competing interests None declared.
Ethics approval Commissie mensgebonden onderzoek (CMO).
Provenance and peer review Not commissioned; internally peer reviewed.