NCT05178745

Resection Observatory

A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The estimated inclusion period is 45 months. Patient follow-up is 24 months and the total study duration is 69 months. Last patient status (alive or dead) collected before database lock.

Conditions

• Metastatic Colorectal Cancer
• Colorectal Neoplasms

Interventions

Type	Name	Description
DRUG	Fluorouracil	Pharmaceutical Form: solution for injection Route of Administration: intravenous (IV), intravenous or intra-arterial infusion
DRUG	Aflibercept	Pharmaceutical Form: concentrate solution for infusion Route of Administration: IV infusion
DRUG	Irinotecan	Pharmaceutical Form: solution for injection Route of Administration: IV infusion

Timeline

• Start date: 2016-09-07
• Primary completion: 2022-05-27
• Completion: 2022-05-27
• First posted: 2022-01-05
• Last updated: 2025-01-30