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

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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