Conditions: Colorectal Cancer
Keywords: Refractory, metastatic colorectal cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 800
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer.

Detailed description:
This is a multinational, double-blind, two-arm, parallel, randomized Phase 3 comparison study evaluating the efficacy and safety of TAS-102 versus placebo in patients with refractory metastatic colorectal cancer. Patients will be randomly assigned (2:1) to TAS-102 (experimental arm) or placebo (control arm).

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: TAS-102 intervention 2: Placebo
Intervention descriptions: intervention 1: 35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met. intervention 2: Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.

Protocol document: