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

NCT07004413 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2025-06-04

No results posted yet for this study

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

Conditions

  • Colorectal Cancer Metastatic

Interventions

DRUG

FOLFIRI+cetuximab

Cetuximab 500 mg/m², 90 min IV infusion on d1; Irinotecan: 180 mg/m², 90-120 min IV infusion on d1; Folinic acid: 400mg/m², 1-2h IV Infusion on d1; 5-FU: 2400 mg/m², 46 h IV infusion on d1. Cycles are repeated on day 15.

DIAGNOSTIC_TEST

Guardant360 ctDNA assay

Determination of circulating tumor DNA (ctDNA) in the peripheral blood, part 1: retrospective threshold determination to predict radiological disease progression in Arm 2; part 2: prospective validation of the in part 1 identified ctDNA threshold to guide the scheduled treatment breaks and treatment in Arm 2

Sponsors & Collaborators

  • Merck Healthcare Germany GmbH, an affiliate of Merck KGaA, Darmstadt, Germany

    collaborator UNKNOWN

  • Guardant Health, Inc.

    collaborator INDUSTRY

  • Charite University, Berlin, Germany

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-01-01
Completion
2031-01-01

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07004413 on ClinicalTrials.gov