Pre-Operative Treatment in REseCTable COlon CanceR

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)).

Timeline

Start

2025-04

Primary completion

2033-04

Completion

2035-04

Publications

• Siegel R, Dittrich L, Plewe J, Denecke T, Leonhardi J, Tannapfel A, Reinacher-Schick A, Raschzok N, Sauer IM, Lauscher J, Lorenzen S, Gotze T, Jelas I, Stahler A, Kurreck A, Ballhausen A, Ostendorf BN, Haase O, Pratschke J, Stintzing S, Modest DP. PROTECTOR / FIRE-10: study protocol for a prospective, randomized, open-label, multicenter phase III trial to investigate the efficacy of preoperative systemic therapy in advanced colon cancer. BMC Cancer. 2026 Mar 20;26(1):454. doi: 10.1186/s12885-026-15682-3.

Drugs

Indications