OncoMatch/Clinical Trials/NCT06501482
Adjuvant FOLFIRI Based-chemotherapy After Resection of CLM Responding to Preoperative FOLFIRI
Is NCT06501482 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Postoperative reintroduction of FOLFIRI based chemotherapy for colorectal cancer.
Treatment: Postoperative reintroduction of FOLFIRI based chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS any tested
Primary tumor (or liver metastasis) of CRC must be characterized for RAS and BRAF status
Required: NRAS any tested
Primary tumor (or liver metastasis) of CRC must be characterized for RAS and BRAF status
Required: BRAF any tested
Primary tumor (or liver metastasis) of CRC must be characterized for RAS and BRAF status
Excluded: UGT1A1 *28 allele homozygosity
Known UGT1A1*28 allele homozygosity
Excluded: DPYD complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥ 150 ng/ml)
complete absence of dihydropyrimidine dehydrogenase (DPD) activity (blood uracil level ≥ 150 ng/ml
Disease stage
Metastatic disease required
Performance status
WHO 0–1
Prior therapy
Must have received: FOLFIRI based chemotherapy — preoperative
At least 2 cycles and no more than 8 cycles of preoperative FOLFIRI based chemotherapy ± targeted therapy
Cannot have received: oxaliplatin-based chemotherapy
Exception: could not be treated with perioperative oxaliplatin-based chemotherapy for oncologic or tolerability reasons
could not be treated with perioperative oxaliplatin-based chemotherapy for oncologic or tolerability reasons
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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