Resection Observatory

Completed

• Conditions: Metastatic Colorectal Cancer; Colorectal Neoplasms
• Interventions: Drug: Fluorouracil; Drug: Aflibercept; Drug: Irinotecan

• Registration Number: NCT05178745
• Lead Sponsor: Sanofi

Brief 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.

Study Timeline

• Study Start: 2016-09-07
• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2021-12-17
• Study First Posted: 2022-01-05
• Primary Completion: 2022-05-27
• Study Completion: 2022-05-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Fluorouracil	Patients with metastatic colorectal cancer and liver metastases treated with FOLFIRI plus aflibercept after failure of an oxaliplatin-based regimen
Cohort 1	Aflibercept	Patients with metastatic colorectal cancer and liver metastases treated with FOLFIRI plus aflibercept after failure of an oxaliplatin-based regimen
Cohort 1	Irinotecan	Patients with metastatic colorectal cancer and liver metastases treated with FOLFIRI plus aflibercept after failure of an oxaliplatin-based regimen

Primary Outcome Measures

Name	Time	Method
Assessment of resection rate (R0/R1)	Up to 24 months	R0 /R1 resection rate after aflibercept + FOLFIRI (resection with histological assessment of margin status)

Secondary Outcome Measures

Name	Time	Method
Progression-free surivival	Up to 69 months	Defined as the time from the date of the first aflibercept administration to the date of the first event (progression, relapse or death). (Relapse in case of complete response due to chemotherapy or surgery)
Histological response of resected patients via modified Blazer assessment	Up to 69 months
Rate of 90-day postoperative complications using DINDO-CLAVIEN classification	Up to 69 months
Overall survival	Up to 69 months	Defined starting from the date of the first aflibercept administration.
Objective Response	Up to 69 months	Assessed according to RECIST and CHUN (radiological assessment) criteria in the exploratory analysis.
Relapse-free surivial	Up to 69 months	Defined as the time from the date of the first aflibercept administration to the date of the first event (progression, relapse or death). (Relapse in case of complete response due to chemotherapy or surgery)
Conversion rate	Up to 69 months	Initially unresectable disease which became resectable after aflibercept + FOLFIRI, with R0/R1 resection).
Histological response of resected patients via Tumor Regression Grade (TRG)	Up to 69 months	Histological response of resected patients via TRG
Histological response of resected patients via Modified Tumor Regression Grade (mTRG)	Up to 69 months	Histological response of resected patients via mTRG,
Histological response of resected patients via Sebagh assessment	Up to 69 months
Histoligical response of resected patients via Blazer assessment	Up to 69 months
Radiological response for all patients using RECIST 1.1 criteria	Up to 69 months
Safety (serious and non-serious adverse events occurring during treatment	Up to 69 months	Number of patients with serious and non-serious adverse events occurring during treatment