SAILOR: Multicentre randomised feasibility trial evaluating early Surgery Alone In LOw Rectal cancer

Trial Overview

Acronym	SAILOR
Number	NA
Protocol Link	not included
Public Trial Registry Link	https://doi.org/10.1186/ISRCTN02406823
Status	In Follow-Up
Category	Colorectal Cancer - Rectal Specific
Treatment Course	Surgery

Trial Description

This study seeks to establish the feasibility of a trial to compare high quality early surgery alone for resectable low rectal cancer with standard care (namely pre-operative long course radiotherapy with subsequent surgery). For both arms, post-operative chemotherapy will be available if clinically indicated.

Chief Investigator

Dean Harris
Professor

Profile Link

Lead Centre

Morriston Hospital
Heol Maes Eglwys, Morriston, Cwmrhydyceirw
Swansea
SA6 6NL
Wales

Website

Collaboration and Funding

Funding Sponsors

Additional Information

Full Research Summary

Objective:	• To set up and test the infrastructure necessary to perform a definitive trial. • To test willingness of eligible participant to be randomised to an early surgery-alone arm (with adjuvant chemotherapy post-surgery if clinically indicated). • To quantify the number of participant required for a definitive trial. • To test the ability to recruit, consent and retain participant to the proposed intervention. • To qualitatively explore reasons for non-recruitment. • To test appropriateness and feasibility of collecting the proposed outcomes measures for a full trial.
Aim:	To establish whether a future definitive trial comparing surgery (modern abdominoperineal excision of the rectum (APER) or low anterior resection (LAR)) alone with standard care (preoperative long course radiotherapy then surgery) is feasible.
Methods:	Prospective randomised feasibility multicentre trial
Reason for International Trial:	not international