Skip to main content
OpenTrials
Completed

NCT Number: NCT05178745

Resection Observatory

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluorouracil

Drug

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

aflibercept

Drug

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

Other names: ZALTRAP®

Irinotecan

Drug

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

Other names: CAMPTOSAR®

Primary outcomes

  1. Assessment of resection rate (R0/R1)

    Time frame: Up to 24 months

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

Secondary outcomes

  1. Overall survival

    Time frame: Up to 69 months

    Defined starting from the date of the first aflibercept administration.

  2. Progression-free surivival

    Time frame: 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)

  3. Relapse-free surivial

    Time frame: 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)

  4. Objective Response

    Time frame: Up to 69 months

    Assessed according to RECIST and CHUN (radiological assessment) criteria in the exploratory analysis.

  5. Conversion rate

    Time frame: Up to 69 months

    Initially unresectable disease which became resectable after aflibercept + FOLFIRI, with R0/R1 resection).

  6. Histological response of resected patients via Tumor Regression Grade (TRG)

    Time frame: Up to 69 months

    Histological response of resected patients via TRG

  7. Histological response of resected patients via Modified Tumor Regression Grade (mTRG)

    Time frame: Up to 69 months

    Histological response of resected patients via mTRG,

  8. Histoligical response of resected patients via Blazer assessment

    Time frame: Up to 69 months

  9. Histological response of resected patients via modified Blazer assessment

    Time frame: Up to 69 months

  10. Histological response of resected patients via Sebagh assessment

    Time frame: Up to 69 months

  11. Radiological response for all patients using RECIST 1.1 criteria

    Time frame: Up to 69 months

  12. Rate of 90-day postoperative complications using DINDO-CLAVIEN classification

    Time frame: Up to 69 months

  13. Safety (serious and non-serious adverse events occurring during treatment

    Time frame: Up to 69 months

    Number of patients with serious and non-serious adverse events occurring during treatment

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Prospective Observational Cohort Study Evaluating Resection Rate in Patients With Metastatic Colorectal Cancer Treated With Aflibercept in Combination With FOLFIRI - Observatoire résection

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2022
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.