Clinical Trial

Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)

Recruiting Phase 3
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Summary
This is an open-label, randomized, controlled, multicenter, phase III study with two parallel arms. Patients with metastatic colorectal cancer after definite interventional therapy of all lesions are randomized in a 2:1 fashion (favoring active therapy) to investigate the efficacy, patient reported quality of life and safety of mFOLFOXIRI/mFOLFOX-6 as additive treatment (Arm A) versus active follow-up/surveillance (Arm B).
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2021-08-12; most recent amendment 2025-12-05.
Status change: Not Yet Recruiting → Recruiting 2021-11-29
Trial Details
NCT Number NCT05008809
Lead Sponsor Dominik Paul Modest
Collaborators: German Research Foundation, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Conditions Colorectal Cancer
Enrollment 507 participants
Start Date 2021-12-06
Primary Completion 2027-11 (estimated)
Study Completion 2030-11 (estimated)
Updated on ClinicalTrials.gov 2025-12-12