Cancer types
  • Digestive tract
Title of study
Can the Rectum be Saved by Watchful Waiting or TransAnal Surgery Following (Chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer?
Version Number
Approval Date 
4.0, 17 August 2016
Short Title
Star-Trec
Study site
Principle Investigator
Mr Simon Bach National Surgical Lead for the UK University Hospitals, Birmingham, UK Nederland: Professor Hans De Wilt National Surgical Lead for The Netherlands Radboud University, Nijmegen Medical Centre, Netherlands
Investigator Maastro
Dr M.Berbée
Sponsor
Radboud Universitair Medisch centrum
Trial registry
Objectives 

STAR-TREC is a phase II feasibility study that will evaluate whether it is possible to accelerate patient recruitment from 2 per month, as attained in the previous TREC study, to 6 per month over a two-year period. This would demonstrate deliverability of a phase III study incorporating 400 patients to evaluate differences in pelvic relapse rates between organ saving and standard surgery . Randomising 70-80 patients per year in phase III would achieve this target in 4 years (including patients treated in phase II)

Primary Endpoint 

1. Year 1: randomise at least 4 cases per month internationally (n=48)
2. Year 2: randomise at least 6 cases per month internationally (n=72)

Secondary Endpoints