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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05178745
• Other study ID #: OBS15624
• Secondary ID: AFLIBL07747
• Status: Completed
• Start date: September 7, 2016
• Est. completion date: May 27, 2022

Study information

• Verified date: January 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 27, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Fluorouracil
Pharmaceutical Form: solution for injection Route of Administration: intravenous (IV), intravenous or intra-arterial infusion
• Aflibercept
Pharmaceutical Form: concentrate solution for infusion Route of Administration: IV infusion
• Irinotecan
Pharmaceutical Form: solution for injection Route of Administration: IV infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

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