Randomized Phase II Study of TS-1 Therapy and TS-1+PSK Therapy Against Unresectable Advanced Gastric Carcinoma and Recurrent Gastric Carcinoma
Tegafur / gimeracil / oteracil potassium (TS-1) is widely used as a first-line drug for
unresectable advanced gastric carcinoma and recurrent gastric carcinoma in Japan and the
response rate of TS-1 against gastric carcinoma was reported to be excellent at 46.5% in a
phase II study. However, since adverse drug reactions tend to occur in patients treated with
standard regimen of TS-1, drug reduction or discontinuation is often required, which is one
drawback of this drug. On the other hand, although Krestin (PSK) has been reported to show
survival effects in postoperative immunochemotherapy against gastric carcinoma, the efficacy
of PSK has not been established in patients with unresectable advanced gastric carcinoma and
recurrent gastric carcinoma. Since the main effect of PSK was to recover physiological
functions, including immune function of the host, it was expected that PSK would improve the
compliance of TS-1 by alleviating adverse drug reactions of TS-1 therapy and the concomitant
use of TS-1 with PSK would result in the improvement of treatment results. Therefore, we
decided to conduct a randomized phase II study on patients with unresectable advanced
gastric carcinoma and recurrent gastric carcinoma to compare TS-1 therapy with TS-1+PSK
therapy.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
progression-free survival
6 months
No
Hideaki Tahara, MD
Study Chair
Eastern Network of Cancer Immunological Therapy, Japan
Japan: Institutional Review Board
ENCITJ-GC01
NCT00503321
October 2006
August 2011
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