Status and phase
Conditions
Treatments
About
This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone.
Full description
This is a randomized, controlled, open-label, parallel, multicenter study. Patients are stratified according to 3 factors ; performance status (ECOG scale: 0, 1, 2), disease stage (unresectable gastric cancer or recurrent gastric cancer (received prior adjuvant chemotherapy or not)) and participating center. Patients are randomized to one of two treatment arms. Arm A: Patients receive oral TS-1 twice daily on days 1-28 followed by 14 days rest. Treatment is repeated every 42 days for up to 4 courses. Arm B: Patients receive CDDP iv on day 8 and oral TS-1 twice daily on days 1-21 followed by 14 days rest. Treatment is repeated every 35 days for up to 5 courses. Patients are followed every 6 months for up to 2 years from the day they participates in this study.
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
300 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal