Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type m… (NCT07004413) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Continuous or Intermittent Cetuximab Plus FOLFIRI as First-line Treatment in RAS/BRAF Wild-type mCRC Patients
Germany267 participantsStarted 2026-01-01
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient's signed informed consent
✓. Histologically confirmed, UICC stage IV unresectable adenocarcinoma of the colon or rectum
✓. Locally confirmed RAS/BRAF wild-type tumor status (KRAS and NRAS exon 2, 3, 4, BRAF exon 11/15)
✓. Centrally confirmed RAS/BRAF wild-type status by liquid biopsy during screening phase
✓. Age 18 or older at the time of written informed consent
✓. ECOG performance status below or equal 1
✓. Presence of at least one measurable reference lesion according to the RECIST 1.1 criteria
✓. Archival tumor tissue available
Exclusion criteria
✕. Proof of a RAS or BRAF mutation (KRAS/NRAS exons 2, 3, 4 or BRAF exon 15) in the tumor (proven in the primary tumor or metastasis) or liquid biopsy during screening phase.
✕
What they're measuring
1
Progression-free survival (PFS) on treatment rate at 12 months
. Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before written informed consent.
✕. New York Heart Association Class III or greater heart failure by clinical judgement.
✕. Myocardial infarction, balloon angioplasty (PTCA) with or without stenting, and cerebral vascular accident/stroke within the past 12 months before randomization