Phase III Randomized Controlled Study of Postoperative Adjuvant Therapy Using TS-1 or TS-1+PSK for Stage II or III Gastric Cancer Patients
TS-1 is an oral anticancer drug approved in Japan consisting of tegafur (a pro-drug of
fluorouracil, 5-FU), gimeracil and oteracil potassium. The response rate of TS-1 in the
untreated advanced gastric cancer patients was 44.6% in the late phase II study. In 2007,
efficacy of the adjuvant therapy using TS-1 in the resected gastric cancer patients was
demonstrated by ACTS-GC study group conducted in Japan. PSK is an oral anticancer drug
approved in Japan consisting of protein-bound polysaccharide extracted from mycelium of
Trametes (Coriolus) versicolor, a kind of mushroom. Even though survival benefit by PSK in
combination with adjuvant chemotherapy using 5-FU or tegafur in the postoperative gastric
cancer patients was already demonstrated, it is not uncertain about efficacy of combination
therapy with PSK and TS-1 in gastric cancer. In this study, we compare efficacy and safety
of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric
cancer patients.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Relapse-free survival
Five years after surgery
No
Masatsugu Kitamura, MD
Study Chair
Japan: Ministry of Health, Labor and Welfare
TMOG-GC01
NCT00687843
June 2008
March 2016
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