Study Design

Patients diagnosed with low rectal cancer (<6cm anal verge) requiring surgery will be potentially eligible.
Participants will be randomised to either:
a) Standard care (long course radiotherapy then surgery) or
b) Early surgery alone as the intervention arm

Type of study eg RCT                                              

Prospective 1:1 randomised feasibility multicentre trial.

Sample size

80 patients with rectal cancer

Objectives

Primary objective:
To establish whether a future definitive trial comparing surgery (modern abdominoperineal excision of the rectum (APER)) alone with standard care(preoperative long course radiotherapy then surgery) is feasible.
Secondary objectives:
  • 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.
  For further information, please go to http://www.isrctn.com/ISRCTN02406823