ZETA : Prospective Observational Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Metastatic Colon Cancer

Intervention / Treatment
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* Combination Product: aflibercept + FOLFIRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Combination Product: aflibercept + FOLFIRI|aflibercept + FOLFIRI|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | progression-free survival (PFS) | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic, colon cancer