Adjuvant FOLFIRI Based-chemotherapy After Resection of CLM Responding to Preoperative FOLFIRI

NCT06501482 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Phase 3

Started

2025-06-27

Last updated

2026-09-09

Condition(s) studied

Colorectal CancerColorectal Liver Metastases

Investigational drug(s) / intervention(s)

Postoperative reintroduction of FOLFIRI based chemotherapy

Postoperative reintroduction of FOLFIRI based chemotherapy: Postoperative reintroduction of FOLFIRI: irinotecan 180 mg/m2 + leucovorin 400 mg/m2 at day 1 then 5-FU 400 mg/m2 bolus followed by 2400 mg/m2 continuous infusion over 46 h biweekly. For a total of 12 cycles of perioperative chemotherapy including the preoperative chemotherapy

Study summary

Eligible patients are patients with contraindication to preoperative oxaliplatin based-chemotherapy who underwent resection of no more than 10 colorectal liver metastases after preoperative FOLFIRI based chemotherapy with or without targeted agents. These patients must have objective response to treatment (radiologic or pathologic response). The standard care for these patients is no postoperative treatment although benefit of reintroduction of FOLFIRI chemotherapy in good responders could be expected.

This study is a National, multicenter, open-label randomized, 2-arm, phase III superiority trial comparing postoperative reintroduction of FOLFIRI based-chemotherapy (experimental arm) vs no treatment (control arm) in patients undergoing resection of colorectal liver metastases after good response to FOLFIRI-based chemotherapy with or without targeted agent.

The primary endpoint of the study is 3-year disease free survival. Based on published data, 3-year DFS in control group (absence of postoperative treatment is 25%. Expected 3-year DFS in the experimental group is 40%. The study will randomize 254 patients (127 in the chemotherapy group and 127 in the no treatment group) in 30 french academic centers.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Histologically proven resected metachronous CLM with curative intent that could not be treated with perioperative oxaliplatin-based chemotherapy for oncologic or tolerability reasons. For this study, metachronous CLM is defined as liver recurrence occurring more than 12 months after treatment of the primary colorectal cancer. * No more than 10 treated CLM at surgery * At least 2 cycles and no more than 8 cycles of preoperative FOLFIRI based chemotherapy ± targeted therapy. * Preoperative FOLFIRI based chemotherapy ± targeted therapy administered no more than 12 weeks before surgery * R0/R1resection ± radiofrequency ablation with curative intent of all liver deposits with no macroscopic residual liver disease * Objective response to preoperative therapy defined as complete or partial radiological response and/or major or complete pathologic response or stable desease * No extrahepatic or residual liver disease on baseline work-up including thoraco-abdominal CT scan within 6 weeks after surgery. 1 non-specific lung nodule of less than 10 mm in maximum diameter is not considered as extra-hepatic metastases * Primary tumor (or liver metastasis) of CRC must be characterized for RAS and BRAF status * No contraindication to FOLFIRI based chemotherapy * Patients must be 18 years old or older * A WHO performance status of 0 or 1 * Participants must be affiliated to a social security scheme Exclusion Criteria: * Palliative/R2 resection of CLM * 10 lesions or more treated at the time of surgery * Patients undergoing only radiofrequency ablation of all liver deposit (this situation precludes the assessment of pathologic response to preoperative chemotherapy) * Extra-hepatic or residual metastasis of CRC * Absence of objective response to therapy (radiological or pathological response ) * Inflammatory bowel disease * Known UGT1A1\*28 allele homozygosity * complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥ 150 ng/ml * Contraindications to investigational medicinal products (irinotecan, 5-FU, folinic acid) and to auxiliary medicinal products (ondansetron, methylprednisolone) * Persistent toxicity ≥ grade 1 related to preoperative FOLFIRI based chemotherapy * Known pregnancy (pregnancy test for women of childbearing) or breastfeeding women

Primary outcome measure(s)

The disease-free survival rate — 3 years
Disease-free survival rate at 3 years defined as the proportion of surviving patients without disease recurrence measured by Kaplan-Meier in the two treatment arms from the time to randomization. Disease-free survival will be defined as follows: time between randomization and disease recurrence or death whichever occurs first. In this trial, the disease-free survival is defined as the time to occurrence of first recurrence or death whatever comes first. Diagnosis of recurrence can be made only when the clinical and laboratory findings meet at least one of the criteria defined below: * Objective radiological recurrence on radiological imaging (ultrasound, CT scan, MRI scan, TEP scan as indicated by the clinical picture) * Positive cytology or biopsy (in case of ascites, anastomotic recurrence, doubt on radiological imaging) Note: an isolated elevated tumor marker level will not be considered acceptable evidence of cancer recurrence. * Death.

Trial sites (1)

Facility	City	Region	Status
Hôpital Kremlin Bicêtre	Paris	Île-de-France Region	Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions Active, not recruiting

neonAtal motoR paTtErn autoMatIc analySis Recruiting

Characterisation of Intestinal Microbiota of Patients With Spondyloarthritis or Rheumatoid Arthritis Recruiting

Effect of Adding Vasopressin on Cardiac Output, Blood Pressure, Diuresis, and Tissue Perfusion Indices in Patients With Septic Shock Starting soon

Efficacy of Methylprednisolone Pulses in Neuroendocrine Celles Hyperplasia of Infancy : An Early Phase Study Recruiting

Other trials for the same condition

Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008). Active, not recruiting

A Study to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of VVD-133214 as Monotherapy and in Combination in Participants With Advanced Solid Tumors Recruiting

Feasibility and Benefits of Reflexology in the Prevention of Neuropathy Induced by Oxaliplatin in Colorectal Cancer Recruiting

Assessment of Adherence to Remotely Monitored Physical Activity Tracked on a Smartwatch, and Its Impact on Reducing Fatigue 3 Months After Adjuvant Chemotherapy for Cancer Recruiting

Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06501482 on ClinicalTrials.gov ↗ ← All trials in France