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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether giving a specific type of chemotherapy called FOLFIRI after surgery can help patients with colorectal cancer that has spread to the liver. The trial is for patients who have had good responses to FOLFIRI before surgery but could not use another chemotherapy called oxaliplatin for various reasons. The main goal is to see if patients who receive the FOLFIRI treatment after surgery have a better chance of staying cancer-free for three years compared to those who do not receive any further treatment.

To participate in this trial, patients must be at least 18 years old and have had surgery to remove up to 10 liver tumors caused by colorectal cancer. They should have responded well to FOLFIRI chemotherapy before surgery and have no signs of cancer left after the operation. The trial will involve about 254 patients across 30 centers in France, and participants will be randomly assigned to either receive the chemotherapy or no additional treatment. The trial is not yet recruiting participants, so those interested will need to wait for it to start.

Gender

ALL

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
• • 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