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Name of the study

A Multi-centred randomised trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancer

Researchers and contact information

Principal Investigators:

Dr. J.B. Tuynman

VU Medical Center

De Boelelaan 1117

1007 MB Amsterdam

Location ZH 7F 20

Trial coordinator:

Stefan E. van Oostendorp

Summary study

In this multicentre randomised trial, patients with an intermediate risk T1-2 rectal cancer, that has been locally excised using an endoluminal technique, will be randomised between adjuvant chemo-radiotherapy limited to the mesorectum and standard completion total mesorectal excision (TME). To strictly monitor the risk of locoregional recurrence in the experimental arm and enable early salvage surgery, there will be additional follow up with frequent MRI and endoscopy. The primary outcome of the study is three-year local recurrence rate. Secondary outcomes are morbidity, disease free and overall survival, stoma rate, functional outcomes, health related quality of life and costs. The design is a non inferiority study with a total sample size of 302 patients .


Arm A

Completion TME

Arm B

Adjuvant chemoradiotherapy (25x1.8 Gy + Capecitabine)