Actively Recruiting
Adjuvant FOLFIRI Based-chemotherapy After Resection of CLM Responding to Preoperative FOLFIRI
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-04
254
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 with curative intent not treated with oxaliplatin-based chemotherapy due to oncologic or tolerability reasons
- No more than 10 colorectal liver metastases treated at surgery
- Received between 2 and 8 cycles of preoperative FOLFIRI based chemotherapy with or without targeted therapy
- Preoperative FOLFIRI based chemotherapy given no more than 12 weeks before surgery
- R0 or R1 resection with or without radiofrequency ablation aiming to remove all liver tumors with no visible residual disease
- Objective response to preoperative therapy defined as complete or partial radiological response and/or major or complete pathologic response
- No extrahepatic or residual liver disease on baseline work-up including thoraco-abdominal CT scan within 6 weeks after surgery
- Primary colorectal 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
- 10 or more lesions treated at surgery
- Only radiofrequency ablation of all liver deposits without surgery
- Extrahepatic or residual colorectal cancer metastases
- No objective response to preoperative therapy
- History of inflammatory bowel disease
- Known homozygosity for UGT1A1*28 allele
- Complete absence of dihydropyrimidine dehydrogenase (DPD) activity
- Contraindications to irinotecan, 5-FU, folinic acid, or related supportive medications
- Persistent toxicity grade 1 or higher from preoperative FOLFIRI chemotherapy
- Known pregnancy or breastfeeding women
AI-Screening
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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
CONTACT
A
Antoine BROUQUET, MHD, PHD
CONTACT
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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