Resection Observatory

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-07

Study Completion Date

2022-05-27

Brief Summary

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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.

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Detailed Description

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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

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Metastatic Colorectal Cancer Colorectal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

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

Fluorouracil

Intervention Type DRUG

Pharmaceutical Form: solution for injection Route of Administration: intravenous (IV), intravenous or intra-arterial infusion

Aflibercept

Intervention Type DRUG

Pharmaceutical Form: concentrate solution for infusion Route of Administration: IV infusion

Irinotecan

Intervention Type DRUG

Pharmaceutical Form: solution for injection Route of Administration: IV infusion

Interventions

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Fluorouracil

Pharmaceutical Form: solution for injection Route of Administration: intravenous (IV), intravenous or intra-arterial infusion

Intervention Type DRUG

Aflibercept

Pharmaceutical Form: concentrate solution for infusion Route of Administration: IV infusion

Intervention Type DRUG

Irinotecan

Pharmaceutical Form: solution for injection Route of Administration: IV infusion

Intervention Type DRUG

Other Intervention Names

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ZALTRAP® CAMPTOSAR®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No