STAR-TREC phase 3
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 drs. N.G. Greijdanus
Tel: +316-20767015 / 024-3092383
The STAR-TREC trial is a multicentre international phase III study, partially randomised, 2-arm parallel, 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. A patient preference model is incorporated in the study and eligible patients can choose for either standard TME surgery (control) or organ saving strategies. Those who prefer organ preservation will be randomised 1:1 between chemoradiotherapy or 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. TME surgery will be performed in case of poor clinical regression.
Additionally, biomarker research will be performed. Genomic markers will be investigated in blood samples (ctDNA) associated with persistence of tumour tissue following organ-preserving treatment. The utility of ctDNA to determine partial versus complete response will be evaluated. The primary endpoint of this phase III study is the proportion of patients with successful organ preservation at 30 months from the start date of (chemo)radiotherapy.
Arm A: standard TME surgery
Arm B: organ preservation
- Arm B1: 25x2 Gy and capecitabine
- Arm B2: 5x5 Gy