Introduction There are 11 500 rectal cancers diagnosed annually in the UK. Although surgery remains the primary treatment, there is evidence that preoperative radiotherapy (RT) improves local recurrence rates. High-quality surgery in rectal cancer is equally important in minimising local recurrence. Advances in MRI-guided prediction of resection margin status and improvements in abdominoperineal excision of the rectum (APER) technique supports a reassessment of the contribution of preoperative RT. A more selective approach to RT may be appropriate given the associated toxicity.
Methods and analysis This trial will explore the feasibility of a definitive trial evaluating the omission of RT in resectable low rectal cancer requiring APER. It will test the feasibility of randomising patients to (1) standard care (neoadjuvant long course RT±chemotherapy and APER, or (2) APER surgery alone for cT2/T3ab N0/1 low rectal cancer with clear predicted resection margins on MRI. RT schedule will be 45 Gy over 5 weeks as current standard, with restaging and surgery after 8–12 weeks. Recruitment will be for 24 months with a minimum 12-month follow-up.
Objectives Objectives include testing the ability to recruit, consent and retain patients, to quantify the number of patients eligible for a definitive trial and to test feasibility of outcomes measures. These include locoregional recurrence rates, distance to circumferential resection margin, toxicity and surgical complications including perineal wound healing, quality of life and economic analysis. The quality of MRI staging, RT delivery and surgical specimen quality will be closely monitored.
Ethics and dissemination The trial is approved by the Regional Ethics Committee and Health Research Authority (HRA) or equivalent. Written informed consent will be obtained. Serious adverse events will be reported to Swansea Trials Unit (STU), the ethics committee and trial sites. Trial results will be submitted for peer review publication and to trial participants.
Trial registration number ISRCTN02406823.
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Contributors DAH and JB are responsible for the idea for the trial. DAH, KT, HH, SI, GH, OH, SG, IJ, PC, MD, MF, DCW, SG, PQ, NW, GB, DF, AB and JB have made substantial contributions to the conception and design of the work and subsequent protocol revisions; drafted the manuscript and/or provided critical revision; approved the version submitted for publication; agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Funding This work is supported by Bowel Disease Research Foundation and endorsed by Cancer Research UK (CRUKE/14/050). PQ and NW are funded by Yorkshire Cancer Research. DAH is supported by a Health and Care Research Wales Clinical Research Time award. Sponsor: Abertawe Bro Morgannwg University Health Board will assume overall responsibility for the trial as sponsor.
Competing interests None declared.
Ethics approval Wales REC6.
Provenance and peer review Not commissioned; externally peer reviewed.
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