Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)
Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer Prospective, Randomized, Open, Multicenter Phase III Trial to Investigate the Efficacy of Active Post-resection/Ablation Therapy in Patients With Metastatic Colorectal Cancer
Dominik Paul Modest
507 participants
Dec 6, 2021
INTERVENTIONAL
Summary
This is an open-label, randomized, controlled, multicenter, phase III study with two parallel arms. Patients with metastatic colorectal cancer after definite interventional therapy of all lesions are randomized in a 2:1 fashion (favoring active therapy) to investigate the efficacy, patient reported quality of life and safety of mFOLFOXIRI/mFOLFOX-6 as additive treatment (Arm A) versus active follow-up/surveillance (Arm B).
Eligibility
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Interventions
Oxaliplatin: 85 mg/m², 2h IV infusion on d1 Folinic acid: 400 mg/m², 1-2 h IV infusion on d1 5-FU: (optional: 400 mg/m² bolus, 2-5 min IV infusion), 2400 mg/m², 46 h IV infusion on d1 Cycles are repeated on day 15. A total of up to 12 cycles are administered.
Oxaliplatin: 85 mg/m², 2h IV infusion on d1 Irinotecan: 150 mg/m², 90 min IV infusion on d1 Folinic acid: 400 mg/m², 1-2 h IV infusion on d1 5-FU: 2400 mg/m², 46 h IV infusion on d1 Cycles are repeated on day 15. A total of up to 12 cycles are administered.
Folinic acid: 400mg/m², 1-2h IV Infusion on d1 5-FU: 2400 mg/m², 46 h IV infusion on d1 Irinotecan: 180 mg/m², 90-120 min IV infusion on d1 Cycles are repeated on day 15. A total of up to 12 cycles is administered.
Capecitabine: 1000 mg/m², oral 1-0-1 on d1-14 Oxaliplatin: 130 mg/m², 3h IV infusion on d1 Cycles are repeated on day 22. A total of up to 8 cycles isadministered.
Locations(79)
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NCT05008809