Randomized Multicenter Controlled Phase III Study of Postoperative Adjuvant Therapy for Stage II/IIIA Gastric Cancer Using TS-1 Alone or TS-1+PSK Combined Therapy
The 5-year survival after gastric cancer surgery remains poor as the cancer advances to
stages II, IIIA, IIIB and IV. Tegafur-gimeracil-oteracil potassium (TS-1) is used as the
first line treatment for advanced and recurrent gastric cancer. But TS-1 is accompanied by
an adverse drug reaction of bone marrow suppression that is not readily seen in conventional
oral fluoropyrimidines. Among randomized controlled trials on postoperative adjuvant
chemotherapy for gastric cancer, the beneficial results of survival rates using Krestin
(PSK) in combination with chemotherapy have been reported. With the objective to enhance the
antitumor effect of TS-1 and to improve the QOL of patients, we have planned to validate the
clinical significance of combined PSK and TS-1 therapy as postoperative adjuvant therapy for
gastric cancer, using in principle the TS-1 regimen of 2-week dosing 1-week off for 6 months
followed by 2-week dosing 2-week off for 6 months.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time of recurrence (calculation of 3-year disease-free survival and overall survival rates)
Five years after surgery
No
Koichi Miwa, MD, PhD
Study Chair
Hokuriku-Kinki Immunochemotherapy Study Group
Japan: Ministry of Health, Labor and Welfare
HKIT-GC
NCT00216034
March 2005
February 2016
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