A randomized phase III study comparing S-1 plus docetaxel with S-1 alone as a postoperative adjuvant chemotherapy for curatively resected stage III gastric cancer (JACCRO GC-07 trial).

4007Background: Although postoperative adjuvant chemotherapy with S-1 is among the standard treatmentsfor curatively resected pStage II/III gastric cancer (GC) in Asia, the outcome of pStage III GC remains unsatisfactory. Postoperative S-1/ docetaxelhad been among candidates for the new standard treatment. Methods: JACCRO GC-7, a randomized controlled trial to explore postoperative S-1/ docetaxel, was participated by 138 Japanese institutions. After R0 resection by D2 gastrectomy, patients with pStage III GC were randomly assigned to either the S-1/ docetaxelgroup (oral S-1 at 80-120mg/body on days 1-14 with 7 days of rest was followed by 6 cycles of S-1 at the same dosage and schedule combined with docetaxel40mg/m2 on day 1 of each cycle, and then 4 further cycles of S-1 at 80-120mg/body on days 1-28 every 42 days) or the control group (8 cycles of S-1 at 80-120mg/body on days 1-28 every 42 days). Block randomization was performed by a central interactive computerized system stratified by the institutio...