Trials / Active Not Recruiting
Active Not RecruitingNCT02980510
Comparison FOLFIRINOX Panitumumab vs mFOLFOX6 Panitumumab in RAS/B-RAF Wild-type Metastatic Colorectal Cancer Patients
Phase II Randomized Study Comparing FOLFIRINOX + Panitumumab Versus mFOLFOX6 + Panitumumab in Metastatic Colorectal Cancer Patients Selected by RAS and B-RAF Status From Circulating DNA Analysis
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 219 (actual)
- Sponsor
- UNICANCER · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
National trial, multicenter, randomized, phase II assessing FOLFIRINOX + Panitumumab versus mFOLFOX6 + Panitumumab in metastatic colorectal cancer patients selected by RAS and B-RAF status from circulating DNA analysis. Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab.
Detailed description
PRIMARY OBJECTIVE: Evaluation of complete response rate on treatment combining FOLFIRINOX and panitumumab SECONDARY OBJECTIVE(S): * Overall Survival * Progression free survival * Secondary resection * Early tumor shrinkage (ETS) * Depth of response (DpR) * Safety profile (NCI-CTCAE v4.03 classification) * Diagnostic performance of ccfDNA analysis compared to the tumor-tissue analysis (current gold standard)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil | |
| DRUG | Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil, irinotecan |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2025-12-01
- Completion
- 2026-01-01
- First posted
- 2016-12-02
- Last updated
- 2025-02-20
Locations
6 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02980510. Inclusion in this directory is not an endorsement.