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Resection Observatory

CompletedN/A

Sponsor: Sanofi

Conditions: Metastatic Colorectal Cancer, Colorectal Neoplasms

Interventions: Fluorouracil, Aflibercept, Irinotecan

Primary Objective: -Evaluate the resection rate (R0/R1) in current practice for aflibercept in combination with irinotecan plus 5-fluorouracil (FOLFIRI) in patients treated for metastatic colorectal cancer (mCRC) after failure of an oxaliplatin-containing regimen Secondary Objectives: * Evaluate overall survival, progression-free survival and relapse-free survival. * Evaluate conversion rates (initially unresectable disease which became resectable after chemotherapy, with R0/R1 resection). * Evaluate histological and radiological response rates. * Evaluate rate of postoperative complications. * Evaluate safety.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* All patients treated with aflibercept in combination with FOLFIRI for mCRC after failure of an oxaliplatin-containing regimen (including patients pretreated with bevacizumab or anti-EGFR and patients treated with oxaliplatin in the adjuvant setting).
* Exclusively or predominantly hepatic metastases (≤ 5 pulmonary nodules \< 2 cm).
* Age \> 18 years.
* Signed consent for collection of personal and medical data.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Exclusion Criteria:

* Concomitant participation in a clinical trial.
* Patient receiving concomitant anti-VEGF agents and/or receiving aflibercept as part of a clinical trial or in a compassionate use program.
* Patient receiving aflibercept in combination with chemotherapy other than FOLFIRI.
* Patient with contra-indication to surgery.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.