Actively Recruiting
Interest of Postoperative Reintroduction of Chemotherapy in Patients Undergoing Resection of Colorectal Liver Metastases After Good Response to FOLFIRI-based Chemotherapy With or Without Targeted Agent (Intergroup FRENCH-PRODIGE)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-04
254
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a treatment approach for patients with colorectal liver metastases (CLM) who cannot receive oxaliplatin-based chemotherapy before surgery due to medical reasons. This national, multicenter, open-label phase III trial compares the effect of restarting FOLFIRI-based chemotherapy after liver surgery versus no postoperative treatment. The study aims to improve the rate of disease-free survival three years after surgery. Participants in the experimental group receive a combination of irinotecan, leucovorin, and 5-fluorouracil (5-FU) administered biweekly for a total of 12 chemotherapy cycles including those before surgery. The control group does not receive any treatment after surgery. The trial includes patients who had a good response to preoperative FOLFIRI chemotherapy and underwent resection of up to 10 liver metastases. During the study, participants will be monitored for disease recurrence and survival outcomes over a follow-up period that may last up to six years. Assessments include imaging scans to confirm no residual disease, evaluation of tumor response, and regular health status checks. The primary outcome measured is the disease-free survival rate at three years, with secondary outcomes including overall survival and liver-specific survival rates.
CONDITIONS
Brief Title
Adjuvant FOLFIRI Based-chemotherapy After Resection of CLM Responding to Preoperative FOLFIRI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically proven resected metachronous colorectal liver metastases (CLM) with curative intent
- Liver recurrence occurring more than 12 months after primary colorectal cancer treatment
- No more than 10 liver metastases treated at surgery
- Received between 2 and 8 cycles of preoperative FOLFIRI-based chemotherapy with or without targeted therapy
- Preoperative chemotherapy administered no more than 12 weeks before surgery
- R0 or R1 resection with or without radiofrequency ablation, with no visible residual liver disease
- Objective response to preoperative therapy defined by complete or partial radiologic and/or major or complete pathologic response
- No extrahepatic or residual liver disease confirmed by CT scan within 6 weeks after surgery (except one non-specific lung nodule under 10 mm)
- Primary tumor or liver metastasis characterized for RAS and BRAF status
- No contraindication to FOLFIRI-based chemotherapy
- Age 18 years or older
- WHO performance status of 0 or 1
- Affiliated to a social security scheme
You will not qualify if you...
- Palliative or R2 resection of colorectal liver metastases
- Ten or more lesions treated at surgery
- Patients treated only by radiofrequency ablation of all liver deposits
- Presence of extrahepatic or residual metastases of colorectal cancer
- Absence of objective response to preoperative therapy
- Inflammatory bowel disease
- Known UGT1A1*28 allele homozygosity
- Complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥ 150 ng/ml)
- Contraindications to irinotecan, 5-FU, folinic acid, ondansetron, or methylprednisolone
- Persistent toxicity grade 1 or higher related to preoperative FOLFIRI chemotherapy
- Known pregnancy or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 24 weeks (12 biweekly cycles)
Participants in the experimental arm receive postoperative reintroduction of FOLFIRI chemotherapy, which includes irinotecan, leucovorin, and 5-FU, administered biweekly for a total of 12 cycles including preoperative chemotherapy. Participants in the control arm do not receive any adjuvant treatment.
Biweekly visits for up to 12 cycles
Duration - Up to 3 years
Participants are monitored for disease-free survival and overall survival after completing treatment or observation.
Regular follow-up visits scheduled according to study protocol
Trial Site Locations
Total: 1 location
1
Hôpital Kremlin Bicêtre
Paris, Île-de-France Region, France, 75010
Actively Recruiting
Research Team
S
Stéphane BENOIST, MHD, PHD
A
Antoine BROUQUET, MHD, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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