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A Randomized Trial of Adjuvant Chemotherapy with UFT / LV versus PSK / UFT / LV following curative resection for Stage II / III Colorectal Cancer

ABSTRACT: Interventions: Group A (standard therapy group:UFT/LV 6M): Administration of 5 courses (6 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. Group B (trial therapy group: PSK/UFT/LV 6M): Administration of 5 courses (6 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. And administration of every day PSK (3g/body) for 6 months. Group C (trial therapy group: PSK/UFT/LV 12M): Administration of 10 courses (12 months) of a schedule in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. And administration of every day PSK (3g/body) for 12 months. Primary outcome(s): 3 year desease free survival rate Study Design: Parallel Randomized

DISEASE(S): Colorectal Cancer

PROVIDER: 2620921 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Phase III Comparative Clinical Trial of Treatment Schedules for Oral UFT/LV Therapy as Postoperative Adjuvant Chemotherapy for Stage IIB/III Colorectal Cancer

Project description:Interventions: Group A (standard therapy group): Administration of 5 courses (6 months) of a schedule (consecutive administration method) in which one course consists of UFT (300 mg/m2/day) and LV (75 mg/day) for 28 consecutive days followed by 7 days off the drugs. Group B (trial therapy group): Administration of 15 courses (18 months) of a schedule (5 days on, 2 days off: Saturday and Sunday) in which one course consists of 5 weeks of UFT (300 mg/m2/day) and LV (75 mg/day) for 5 consecutive days followed by 2 days off. Primary outcome(s): disease-free survival Study Design: Parallel Randomized

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A study on taking method of adjuvant Tegafur-Uracil and Leucovorin Calcium in patients with resected Colorectal Cancer (Three times-daily regimen Versus twice-daily regimen)

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| 2621031 | ecrin-mdr-crc

Phase III Adjuvant Chemotherapy of S-1 plus Oxaliplatin for Colorecrtal Cancer (ACTS-CC 02)

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| 2610281 | ecrin-mdr-crc

Phase III Adjuvant Chemotherapy of S-1 plus Oxaliplatin for Colorecrtal Cancer (ACTS-CC 02)

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Phase III Adjuvant Chemotherapy of S-1 plus Oxaliplatin for Colorecrtal Cancer

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HiSCO 03 study

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| 2020230 | ecrin-mdr-crc

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