Trials / Completed
CompletedNCT03730558
ZETA : Prospective Observational Study
Non-comparative Prospective Observational Cohort Study Describing the Safety and Efficacy of Aflibercept Administered in Combination With FOLFIRI After Failure Under Oxaliplatin + Anti-EGFR Therapy in the Treatment of Patients With Metastatic Colorectal Cancer in Practice Common
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 120 (actual)
- Sponsor
- Recherche clinique · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | aflibercept + FOLFIRI | aflibercept + FOLFIRI |
Timeline
- Start date
- 2017-11-08
- Primary completion
- 2021-11-08
- Completion
- 2021-11-08
- First posted
- 2018-11-05
- Last updated
- 2025-01-22
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT03730558. Inclusion in this directory is not an endorsement.