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Spots Global Cancer Trial Database for ZETA : Prospective Observational Study

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Trial Identification

Brief Title: ZETA : Prospective Observational Study

Official Title: 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

Study ID: NCT03730558

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Institut Sainte-Catherine, Avignon, Vaucluse, France

Institut Sainte Catherine, Avignon, , France

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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