Status:
NOT_YET_RECRUITING
Adjuvant FOLFIRI Based-chemotherapy After Resection of CLM Responding to Preoperative FOLFIRI
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Colorectal Cancer
Colorectal Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ba...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
September 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2030
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT06501482
Start Date
September 30 2024
End Date
September 30 2030
Last Update
July 15 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Kremlin Bicêtre
Paris, Île-de-France Region, France, 75010