A multicenter randomized, double-blind placebo controlled phase III study of the efficacy of Xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer treated with oxaliplatin/5FU/LV
- Conditions
- Patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV at risk of cumulative peripheral sensory neuropathy PSN relative to cumulative dose of oxaliplatin.MedDRA version: 6.1Level: PTClassification code 10034620
- Registration Number
- EUCTR2005-002570-30-IT
- Lead Sponsor
- SANOFI-SYNTHELABO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
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