Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, TS-1, PSK, Disease-free survival, Overall survival
Eligibility Criteria
Inclusion Criteria: Patients with microscopic stage II or IIIA resectable gastric cancer Patients who have not received preoperative cancer therapy (radiotherapy, chemotherapy or immunotherapy) Patients with serum immunosuppressive acidic protein (IAP) measured within 2 weeks before surgery Patients with no metachronous or synchronous multiple cancer Patients without severe impairment of renal, hepatic and bone marrow functions Patients who are judged to be capable of tolerating surgery Patients with preoperative performance status 0 to 2 Patients with no serious concurrent complications (such as bone marrow suppression, diarrhea and infection) Patients who are judged to be capable of tolerating this treatment, and who have given written informed consent to participate in this study Exclusion Criteria: Patients with fresh hemorrhage from the gastrointestinal tract Patients with retention of body fluid necessitating treatment Patients with infection, intestinal palsy or intestinal occlusion Patients who are pregnant or hope to become pregnant during the study period Patients with diabetes treated by continuous use of insulin or showing poor glycemic control Patients with a history of ischemic heart disease Patients with concurrent psychiatric disease or psychotic symptoms, and judged to have difficulties participating in the study Patients receiving continuous administration of steroids Patients who have experienced serious drug allergy in the past Others, patients judged by the investigator or subinvestigator to be inappropriate as subject
Sites / Locations
- University of Fukui Hospital
- National Hospital Organization Fukui Hospital
- Shakaihoken Kobe Central Hospital
- Public Central Hospital of Matto Ishikawa
- Kanazawa University Hospital
- Ishikawa Prefectural Central Hospital
- Kanazawa Redcross Hospital
- Kanazawa Medical University Hospital
- Fukuchiyama City Hospital
- Kyoto Ohashi General Hospital
- Houyu hospital
- National Hospital Organization Maizuru Medical Center
- Saiseikai Kyoto Hospital
- Nantan General Hospital
- Rokujizo Hospital
- Second Okamoto General Hospital
- Kyoto Prefectural Yosanoumi Hospital
- Marutamachi Hospital
- Osaka City University Hospital
- Sumitomo Hospital
- Matsushita Memorial Hospital
- Midorigaoka Hospital
- Shiga University of Medical Science Hospital
- Saiseikai Shigaken Hospital
- Shimane University Hospital
- Saiseikai Takaoka Hospital
- Kouseiren Takaoka Hoapital
- Toyama Rosai Hospital
- Yatsuo General Hospital
- Kitade Hospital
- Fukui Cardio Vascular Center
- Fukui General Hospital
- Fukui Saiseikai Hospital
- Gifu Municipal Hospital
- Gifu Prefectural General Medical Center
- Gifu University Hospital
- University Hospital, Kyoto Prefectural University of Medicine
- Nishijin Hospital
- Kyoto First Red Cross Hospital
- Nara City Hospital
- Osaka Railway hospital
- Toyama Prefectural Central Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
1
2
TS-1 Group: The group treated with TS-1 mono-therapy
TS-1+PSK Group: The group treated with combination therapy using TS-1 and PSK