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Since 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.
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Tegafur-gimeracil-oteracil potassium (TS-1), Krestin (PSK)
Tokyo Metropolitan Cancer and Infectious Disease Center Komagome Hospital
Tokyo Metropolitan Oncology Group
Published on BioPortfolio: 2014-08-27T03:30:13-0400
A randomized controlled study is conducted on unresectable advanced gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1 + PSK therapy. The primary endpoint ...
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