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Clinical Trial 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.•


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03730558
Study type Observational [Patient Registry]
Source Institut Sainte Catherine
Contact RANIA BOUSTANY, Dr
Phone 0490276161
Email r.boustany@isc84.org
Status Recruiting
Phase
Start date November 8, 2017
Completion date November 8, 2021

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