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Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients

Study acronym: FIRE-11
StatusNot Yet Recruiting
PhasePhase 3
Started2026-10-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Jan 1, 2028 → Oct 1, 2028
See other at-risk trials from Charite University, Berlin, Germany

Amendment history

2026-07-28
critical
Study Status, Sponsor/Collaborators v1
Primary completion pushed: 2028-01-01 → 2028-10-01
Completion pushed: 2031-01-01 → 2031-10-01
Start date2026-01-01→2026-10-01
Collaborators2 entries, revised
Merck Healthcare Germany GmbH, an affiliate of Merck KGaA, Darmstadt, Germany
2025-05-27
minor
Original filing
The goal of this clinical trial is to learn if the application of the chemotherapy FOLFIRI and cetuximab works better when given with scheduled breaks or continuously in adults with metastatic colorectal cancer. The main question it aims to answer is, whether worsening of disease after 12 months of treatment is lower when the treatment is given with breaks or given continuously. It will also answer the question whether the quality of life is better and side effects are less if chemotherapy is given with breaks. Additionally, the treatment breaks will be controlled by blood tests and imaging examinations. A novel blood test will be introduced to investigate, whether worsening of the disease might be detected before the imaging, and whether a quicker reaction by re-starting the therapy would help the patients. Participants will: * receive an established chemotherapy mit FOLFIRI and cetuximab * Receive blood tests every 4 weeks and imaging investigations every 12 weeks * fill out questionnaires to report their quality of life
Trial Details
NCT Number NCT07004413
Lead Sponsor Charite University, Berlin, Germany
Collaborators: Guardant Health, Inc., Merck KGaA, Darmstadt, Germany
Conditions Colorectal Cancer Metastatic
Enrollment 267 participants
Start Date 2026-10-01
Primary Completion 2028-10-01 (estimated)
Study Completion 2031-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-29