Can weSave the rectum by watchful waiting orTransAnal microsurgery following (chemo)Radiotherapy versusTotal mesorectal excision for earlyREctalCancer (STAR-TREC study)?: protocol for a multicentre, randomised feasibility study

Abstract

IntroductionTotal 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 analysisSTAR-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 disseminationThe 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.

Radiotherapy quality assurance for mesorectum treatment planning within the multi-center phase II STAR-TReC trial: Dutch results

“…The STAR-TReC trial is an international multi-center, randomized, phase II study assessing the feasibility of short-course radiotherapy (SC-RT) or long-course chemoradiotherapy (LC-CRT) with subsequent two-stage response assessment as an alternative to TME surgery. Patients are randomized between; a) TME b) organ preservation utilizing LC-CRT and c) organ preservation utilizing SC-RT (ClinicalTrials.gov Identifier: NCT02945566) [11]. A novel target volume is used which includes only the mesorectum [12].…”

Transanal TME: new standard or fad?

“…Although not directly related to TME, the importance of the transanal endoscopic approach might become more prominent in the near future. With the widespread adoption of the watch-and-wait strategy in the treatment of rectal cancer 65,66) , local excision following chemoradiotherapy (CRT) to remove residual tumor and evaluate the effect of CRT has gained ground 67,68) . The role of local excision will thus be more important in the treatment of rectal cancer and this approach will become essential procedure for colorectal surgeons.…”

Robust dose planning objectives for mesorectal radiotherapy of early stage rectal cancer – A multicentre dose planning study

“…In early stage rectal cancer with a low local recurrence risk after radical surgery, patients do not usually receive preoperative radiotherapy. The benefit of organ preservation approaches compared with radical surgery are being evaluated in this setting in the international phase III STAR-TREC trial (ClinicalTrials.gov Identifier: NCT02945566) [1]. This trial focuses on early stage cancer and requires a re-evaluation of target volumes and treatment planning principles.…”

“…This trial focuses on early stage cancer and requires a re-evaluation of target volumes and treatment planning principles. The rationale and development of a novel mesorectumonly target volume for early rectal cancer has been discussed else- where [1,2], but dose planning techniques for this approach have not yet been described.…”