Clinical trial NCT05178745: Resection Observatory
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Colorectal Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-01-05
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of resection rate (R0/R1)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 69 months
measure: Progression-free surivival
timeFrame: Up to 69 months
measure: Relapse-free surivial
timeFrame: Up to 69 months
measure: Objective Response
timeFrame: Up to 69 months
measure: Conversion rate
timeFrame: Up to 69 months
measure: Histological response of resected patients via Tumor Regression Grade (TRG)
timeFrame: Up to 69 months
measure: Histological response of resected patients via Modified Tumor Regression Grade (mTRG)
timeFrame: Up to 69 months
measure: Histoligical response of resected patients via Blazer assessment
timeFrame: Up to 69 months
measure: Histological response of resected patients via modified Blazer assessment
timeFrame: Up to 69 months
measure: Histological response of resected patients via Sebagh assessment
timeFrame: Up to 69 months
measure: Radiological response for all patients using RECIST 1.1 criteria
timeFrame: Up to 69 months
measure: Rate of 90-day postoperative complications using DINDO-CLAVIEN classification
timeFrame: Up to 69 months
measure: Safety (serious and non-serious adverse events occurring during treatment
timeFrame: Up to 69 months
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.