ZETA : Prospective Observational Study
- Conditions
- Metastatic Colon Cancer
- Registration Number
- NCT03730558
- Lead Sponsor
- Recherche clinique
- Brief Summary
Primary objective
- Evaluate the efficacy in terms of progression-free survival (PFS) of aflibercept in combination with FOLFIRI in patients treated routinely for metastatic colorectal cancer (mCRC) after failure of treatment with oxaliplatin + EGFR.
Secondary objective
* Evaluate the efficacy of aflibercept in combination with FOLFIRI on the 2-year overall survival rate and the objective response rate.
* Evaluate the tolerance profile of aflibercept in combination with FOLFIRI.
* Observational study, national, multicenter, cohort, prospective without intervention on the therapeutic strategy.•
- Detailed Description
Inclusion criteria
* All patients expected to be treated with aflibercept in combination with FOLFIRI for a mCRC, after failure of treatment with oxaliplatin + anti-EGFR on the decision of the doctor (situation included in the framework of the MA of aflibercept) .
* Age ≥18 years
* Signature of the agreement for the collection of medical and personal data. (Patients who have received FOLFIRINOX in the first line metastatic are allowed) Note: Failure is defined as progression during or within 6 months after discontinuation of oxaliplatin
Exclusion criteria :
* Concurrent participation in a clinical trial
* Patients who have previously received anti-VEGF agents and / or aflibercept in one trial.
* Patients who received FOLFIRI in the first metastatic line.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the efficacy of aflibercept in terms of progression-free survival (PFS) in association with FOLFIRI in patients treated in common practice for metastatic colorectal cancer (CCRM) after failure of oxaliplatin + anti-EGFR-based treatment 2 years progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Institut Sainte-Catherine
🇫🇷Avignon, Vaucluse, France
Institut Sainte Catherine
🇫🇷Avignon, France