Resection Observatory

Sanofi

Status: Completed

Conditions: Metastatic Colorectal Cancer; Colorectal Neoplasms

Treatments: Drug: Aflibercept; Drug: Fluorouracil; Drug: Irinotecan

Study type: Observational

Funder types: Industry

Identifiers

NCT05178745

OBS15624

AFLIBL07747 (Other Identifier)

U1111-1272-2417 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

140 participants in 1 patient group

Cohort 1

Description:

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

Treatment:

Drug: Irinotecan

Drug: Fluorouracil

Drug: Aflibercept