Spots Global Cancer Trial Database for Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK
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Trial Identification
Brief Title: Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK
Official Title: 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
Study ID: NCT00216034
Conditions
Study Description
Brief Summary: A randomized controlled study is conducted on patients with resected gastric cancer assigned to postoperative adjuvant therapy of TS-1 alone or PSK combined with TS-1, with the objective to examine or validate the outcome, QOL and prognostic factors (host and tumor factors), and explore the factors enhancing the antitumor effect of TS-1.
Detailed Description: 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.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Fukui Hospital, Eiheiji, Fukui, Japan
National Hospital Organization Fukui Hospital, Tsuruga, Fukui, Japan
Shakaihoken Kobe Central Hospital, Kobe, Hyogo, Japan
Public Central Hospital of Matto Ishikawa, Hakusan, Ishikawa, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
Ishikawa Prefectural Central Hospital, Kanazawa, Ishikawa, Japan
Kanazawa Redcross Hospital, Kanazawa, Ishikawa, Japan
Kanazawa Medical University Hospital, Uchinada, Ishikawa, Japan
Fukuchiyama City Hospital, Fukuchiyama, Kyoto, Japan
Kyoto Ohashi General Hospital, Fushimi, Kyoto, Japan
Houyu hospital, Joyo, Kyoto, Japan
National Hospital Organization Maizuru Medical Center, Maizuru, Kyoto, Japan
Saiseikai Kyoto Hospital, Nagaokakyo, Kyoto, Japan
Nantan General Hospital, Nantan, Kyoto, Japan
Rokujizo Hospital, Uji, Kyoto, Japan
Second Okamoto General Hospital, Uji, Kyoto, Japan
Kyoto Prefectural Yosanoumi Hospital, Yosano, Kyoto, Japan
Marutamachi Hospital, Nishinokyokurumazaka-cho, Nakagyou-ku Kyoto, Japan
Osaka City University Hospital, Asahi-machi, Osaka Abeno-ku, Japan
Sumitomo Hospital, Nakanoshima, Osaka Kita-ku, Japan
Matsushita Memorial Hospital, Moriguchi, Osaka, Japan
Midorigaoka Hospital, Takatsuki, Osaka, Japan
Shiga University of Medical Science Hospital, Otsu, Shiga, Japan
Saiseikai Shigaken Hospital, Ritto, Shiga, Japan
Shimane University Hospital, Izumo, Shimane, Japan
Saiseikai Takaoka Hospital, Takaoka, Toyama, Japan
Kouseiren Takaoka Hoapital, Takaoka, Toyama, Japan
Toyama Rosai Hospital, Uozu, Toyama, Japan
Yatsuo General Hospital, Yatsuo, Toyama, Japan
Kitade Hospital, Gobou, Wakayama, Japan
Fukui Cardio Vascular Center, Fukui, , Japan
Fukui General Hospital, Fukui, , Japan
Fukui Saiseikai Hospital, Fukui, , Japan
Gifu Municipal Hospital, Gifu, , Japan
Gifu Prefectural General Medical Center, Gifu, , Japan
Gifu University Hospital, Gifu, , Japan
University Hospital, Kyoto Prefectural University of Medicine, Kyoto, , Japan
Nishijin Hospital, Kyoto, , Japan
Kyoto First Red Cross Hospital, Kyoto, , Japan
Nara City Hospital, Nara, , Japan
Osaka Railway hospital, Osaka, , Japan
Toyama Prefectural Central Hospital, Toyama, , Japan
Contact Details
Name: Koichi Miwa, MD, PhD
Affiliation: Hokuriku-Kinki Immunochemotherapy Study Group
Role: STUDY_CHAIR
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