Resection Observatory

Sponsor
Sanofi
Study ID
NCT05178745
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Jan 5, 2022
Start date
Sep 7, 2016
Status verified
Jan 2025
Primary completion
May 27, 2022
Completion
May 27, 2022

Study Design

Enrollment
140 participants (actual)

Arms

  • Arm: Cohort 1
    Patients with metastatic colorectal cancer and liver metastases treated with FOLFIRI plus aflibercept after failure of an oxaliplatin-based regimen

Primary Outcome Measure

Assessment of resection rate (R0/R1) [ Time Frame: Up to 24 months ]

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