NCT06501482 Adjuvant FOLFIRI Based-chemotherapy After Resection of CLM Responding to Preoperative FOLFIRI
| NCT ID | NCT06501482 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 254 participants |
| Start Date | 2025-06-27 |
| Primary Completion | 2028-06-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 254 participants in total. It began in 2025-06-27 with a primary completion date of 2028-06-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Eric VICAUT, MHD, PHD
STUDY CHAIR
APHP
Frequently Asked Questions
Who can join the NCT06501482 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06501482 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 254 participants.
Is NCT06501482 currently recruiting?
Yes, NCT06501482 is actively recruiting participants. Contact the research team at Stephane.benoist@aphp.fr for enrollment information.
Where is the NCT06501482 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06501482 clinical trial?
NCT06501482 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Eric VICAUT, MHD, PHD at APHP. The trial plans to enroll 254 participants.
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