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
| 1. Bowel Disease Research Fund |
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 |