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

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 Details

NCT ID
NCT06501482
Phase
PHASE3
Sponsor
Assistance Publique - Hôpitaux de Paris
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Postoperative reintroduction of FOLFIRI based chemotherapy
Locations (sample)
  • Paris, Île-de-France Region, France|48.85341,2.3488

Key Eligibility Criteria

  • Histologically proven resected metachronous CLM with curative intent that could not be treated with perioperative oxaliplatin-based chemotherapy fo…
  • 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

For full eligibility, visit ClinicalTrials.gov.

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