Cancer types
Title of study
Rectal preserving treatment for early rectal cancer. A multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer
Version Number
Approval Date 
12, 23 May 2020
Short Title
Study site
Principle Investigator
Dr. J.B. Tuynman dept. of Surgery Amsterdam UMC
Investigator Maastro
Dr J. Buijsen
VU University Medical Centre
Trial registry

The aim of this study is to determine the oncological safety, treatment related morbidity, and the functional outcome of rectal preserving therapy for early rectal cancer; local excision followed by adjuvant chemoradiotherapy is compared to local excision followed by completion radical resection of intermediate risk early rectal cancer.

Primary Endpoint 

The primary outcome of the study is three-year local recurrence rate.

Secondary Endpoints 

Secondary outcomes are short term morbidity (using Comprehensive complication index and the NCI CTCAE Toxicity Criteria), disease free and overall survival, stoma rate, long term morbidity, functional outcomes, health related quality of life (HRQoL) and costs.