Pre-Operative Treatment in REseCTable COlon CanceR

This is an open-label, randomized, controlled, multicenter, phase III study with two parallel arms. Patients with advanced colon cancer, including the upper third of the rectum, clinically staged cT3-4 and or cN+ (defined as lymph nodes with short axis of at least 1cm) are randomized in a 2:1 fashion (favoring preoperative therapy= Arm A) to investigate the efficacy, patient reported quality of life and safety of preoperative mFOLFOXIRI or mFOLFOX-6 or CAPOX followed by surgery versus the standard of care algorithm (surgery followed by stage-guided adjuvant therapy as recommended by the local multidisciplinary tumor board (Arm B)).

NCT Number	NCT06899477
Lead Sponsor	Dominik Paul Modest Collaborators: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Conditions	Colo-rectal Cancer, Colon Cancer, Colon Carcinoma
Enrollment	714 participants
Start Date	2025-04
Primary Completion	2033-04 (estimated)
Study Completion	2035-04 (estimated)
Updated on ClinicalTrials.gov	2025-03-28