Phase II study of TAS-102 in patients with metastatic colorectal cancer

ABSTRACT: Interventions: investigational material(s) Generic name etc : TAS-102 INN of investigational material : Therapeutic category code : 422 Antimetabolic agents Dosage and Administration for Investigational material : TAS-102 70 mg/m2 was administered orally twice a day for 5 days followed by 2 day rest and repeated two times this procedure. control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo was administered orally twice a day for 5 days followed by 2 day rest and repeated two times this procedure. Primary outcome(s): Overall survival To evaluate the overall survivals of TAS-102 versus placebo in patients with chemotherapy-refractory metastatic colorectal cancer Study Design: Randomized, double-blind, placebo-controlled, parallel-group comparative study

DISEASE(S): Patients With Non- Resectable Advanced Metastatic Colorectal Cancer Refractory Or Intolerable To Fluoropyrimidine, Irinotecan And Oxaliplatin, Who Had A History Of Chemotherapy Of 2 Or More Regimens

PROVIDER: 99901 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR