Resection Observatory

NCT05178745 | Completed DMC

• 3 other identifiers: OBS15624AFLIBL07747U1111-1272-2417
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Colorectal Cancer; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Assessment of resection rate (R0/R1)

  R0 /R1 resection rate after aflibercept + FOLFIRI (resection with histological assessment of margin status)

  Up to 24 months

Secondary Outcomes (13)

• Overall survival

  Up to 69 months

• Progression-free surivival

  Up to 69 months

• Relapse-free surivial

  Up to 69 months

• Objective Response

  Up to 69 months

• Conversion rate

  Up to 69 months

Study Arms (1)

Cohort 1

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

Drug: Fluorouracil; Drug: Aflibercept; Drug: Irinotecan

Interventions

Fluorouracil DRUG

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

Cohort 1

Aflibercept DRUG

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

Also known as: ZALTRAP®

Cohort 1

Irinotecan DRUG

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

Also known as: CAMPTOSAR®

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The source population for this study will be patients treated with aflibercept in combination with FOLFIRI for metastatic ColoRectal Cancer (mCRC) after failure of an oxaliplatin-containing regimen (including patients pretreated with bevacizumab or anti-estimated glomerular filtration rate (anti-EGFR) and patients treated with oxaliplatin in the adjuvant setting but excluding these already participating in a clinical trial) recruited from particpating sites in France. The study will aim to enroll approximately 140 adult patients treated with aflibercept in combination with FOLFIRI for metastatic colorectal cancer after failure of an oxaliplatin-containing regimen from up to 30 sites.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Related Publications (1)

• Tougeron D, Bibeau F, Chibaudel B, Kim S, Nguyen T, Phelip JM, Mille D, Bouattour M, Tavan D, Rinaldi Y, Lecomte T, Perrier H, Spaeth D, Caroli Bosc FX, Metges JP, Ferec M, Hautefeuille V, Deslandres-Cruchant M, Danion J, Hammel P, Lewin M, Tasu JP, Angelergues A, DiFiore F, Evrard S, Mansar R, Caillou H, Geffriaud-Ricouard C, Adam R. Resection of colorectal liver metastases with second-line aflibercept plus FOLFIRI: Results from the RESECTION prospective French cohort. Eur J Cancer. 2024 Dec;213:115082. doi: 10.1016/j.ejca.2024.115082. Epub 2024 Oct 22.

  PMID: 39486163 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Fluorouracil; aflibercept; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 5, 2022
• Study Start: September 7, 2016
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share