Study design and statistical analysis
toxicity
SECONDARY
The study was designed as a multicenter randomized phase II study, conducted in accordance with the Declaration of Helsinki, and registered with the University hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN-CTR) (Unique ID issued by UMIN: UMIN000007819) (This study was designed according to a randomized phase II selection design [The secondary endpoints were toxicity, RFS, and OS. A final analysis of survival time was done 5 years after the last enrollment.Significant differences between the categorized groups were compared using the Chi-square test or Fisher’s exact test. For the analyses of continuous values, t-test or Mann-Whitney U test was used. Univariate analysis of the continuation rate of S-1 administration, OS and RFS was performed using the Kaplan-Meier method with log-rank testing as intent-to-treat analyses. We defined 