Cancer types
  • Digestive tract
Title of study
Can we Save the rectum by watchful waiting or TransAnal surgery following (chemo)Radiotherapy versus Total mesorectal excision for early REctal Cancer?
Version Number
Approval Date 
4.3, 5 January 2021 (Dutch Version)
Short Title
STAR-TREC fase III
Study site
Principle Investigator
UK: Mr Simon Bach National Surgical Lead for the UK University of Birmingham, UK NL:Professor Hans De Wilt National Surgical Lead for The Netherlands Radboud University, Nijmegen Medical Centre, Netherlands
Investigator Maastro
Dr M. Berbée
Sponsor
Trial registry
Objectives 

The phase III component will evaluate two contrasting organ preservation strategies (either long-course chemoradiotherapy or short-course radiotherapy) for the treatment of early stage rectal cancer in terms of organ preservation rates, toxicity (clinician and patient-reported) and Health-Related Quality of Life (HRQoL). The phase III study will also include a standard TME radical surgery (non- randomised) comparator arm encompassing reconstructive (low anterior resection) and non-reconstructive (abdominoperineal excision, low Hartmann’s procedure) approaches.

Primary Endpoint 

The proportion of patients with successful organ preservation at 30 months from the start date of (chemo)radiotherapy. Organ preservation is considered to have failed (a) if the rectum is removed; (b) if the patient develops unequivocal locoregional cancer recurrence or (c) if the patient has a stoma.

Secondary Endpoints 
X