Open, randomized, controlled, multicenter phase II study comparing 5-FU/FA plus oxaliplatin FOLFOX-4 plus cetuximab versus 5-FU/FA plus oxaliplatin as first-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer.
- Conditions
- first-line treatment for epidermal growth factor receptor-expressing metastatic colorectal cancer.MedDRA version: 6.1Level: PTClassification code 10061451
- Registration Number
- EUCTR2005-000970-37-IT
- Lead Sponsor
- MERCK S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms explain the synergy between oxaliplatin and cetuximab in EGFR-expressing metastatic colorectal cancer?
How does the FOLFOX-4 plus cetuximab regimen compare to standard-of-care in EGFR-positive mCRC progression-free survival?
Which biomarkers beyond EGFR expression predict response to cetuximab in EUCTR2005-000970-37-IT trial outcomes?
What are the most common adverse events in Merck's FOLFOX-4 plus cetuximab mCRC trial and their management strategies?
How do anti-EGFR therapies like cetuximab compare to anti-VEGF agents in first-line treatment of RAS wild-type metastatic colorectal cancer?