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TAS-102 plus Bevacizumab combination as first-line treatment in elderly patients with metastatic colorectal cancer, phase 2 trial

ABSTRACT: Interventions: TAS-102: 35mg/m2 given orally twice a day in a 28-day cycle, 2-week cycle of 5 days treatment followed by a 2-day rest period, and then a 14-day rest period Bevacizumab: 5mg/kg given intravenously in a 2-week cycle Primary outcome(s): relative dose intensity Study Design: Single arm Non-randomized

DISEASE(S): Metastaic Colorectal Cancer

PROVIDER: 2635519 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Intervention name : TAS-102 Dosage And administration of the intervention : TAS-102 as a starting dose of 25 mg/m2/dose BID (50 mg/m2/day) is administered orally in a 28-day cycle (2-week cycle of 5 days of treatment followed by a 2-day rest period, and then a 14-day rest period). Control intervention name : irinotecan INN of the control intervention : irinotecan Dosage And administration of the control intervention : Irinotecan is administered by intravenous infusion at a dose of 150 mg/m2 over 90 minutes on day 1 and 15. Primary outcome(s): Safety CTCAE (ver.3.0) Study Design: Open-label, multi-center, phase I study

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