Acronym

STAR-TREC

Name of the study

Can we Save the rectum by Watchful waiting or TransAnal microsurgery following (chemo)Radiotherapy versus Total mesorectal excision for early Rectal Cancer?

Researchers and contact information

Prof. dr. J.H.W. de Wilt and R. Stijns

Tel: +316-11159469 / 024-3092383

Email: star-trec@radboudumc.nl

Summary study

The STAR-TREC trial is a multicentre international randomised, 3 arm-parallel, phase II feasibility study in patients with biopsy proven adenocarcinoma of the rectum. Patients with rectal cancer, staged by CT and MRI as ≤ cT3b (up to 5mm of extramural spread) N0M0 can be included. Patients will be randomised to either standard TME surgery (control), organ saving treatment using long course concurrent chemoradiation, or organ saving treatment using short course radiotherapy. For patients treated with an organ saving strategy, clinical response to (chemo)radiotherapy determines the next treatment step. An active surveillance regime will be performed in the case of a complete clinical regression. In the case of incomplete clinical regression, patients will proceed to local excision using an optimized platform such as transanal endoscopic microsurgery. The primary endpoint of this phase II study is to demonstrate sufficient international recruitment in order to sustain a phase III study incorporating pelvic failure as the primary endpoint.

Intervention

Arm A: Standard TME surgery

Arm B: 5x5Gy followed by watchful waiting

Arm C: 25x2Gy and capecitabine followed by watchful waiting