A randomized phase II trial of adjuvant therapy with S-1 plus Hotyu-ekki-to (TJ41) versus S-1 alone for stage II/III gastric cancer - A randomized phase II trial of adjuvant therapy with S-1 plus Hotyu-ekki-to (TJ41) versus S-1 alone for stage II/III gastric cancer (KUGC07)

Results: We randomly assigned 56 patients to group ST and 57 patients to group S. The completion rates of S-1 were 54.5 and 50.9%, the median relative dose intensities were 89.2 and 71.9%, and adverse events of grade 3 or 4 occurred in 45.5 and 54.5% in groups ST and S, respectively. There was no significant difference in 3-year OS or RFS between the two groups.