Overview

Pre-Operative Treatment in REseCTable COlon CanceR

Status:
NOT_YET_RECRUITING
Trial end date:
2035-04-01
Target enrollment:
Participant gender:
Summary
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)).
Phase:
PHASE3
Details
Lead Sponsor:
Dominik Paul Modest
Collaborator:
Frankfurter Institut fr Klinische Krebsforschung IKF GmbH
Treatments:
Fluorouracil
Irinotecan
Leucovorin
Oxaliplatin