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Resection Observatory

NCT05178745 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 140

Last updated 2025-01-30

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-07
Primary Completion
2022-05-27
Completion
2022-05-27

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Entities

Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05178745 on ClinicalTrials.gov