Status:
COMPLETED
Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK
Lead Sponsor:
Hokuriku-Kinki Immunochemotherapy Study Group
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
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...
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00216034
Start Date
March 1 2005
End Date
February 1 2016
Last Update
June 7 2016
Active Locations (42)
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1
Fukui Cardio Vascular Center
Fukui-shi, Fukui, Japan, 910-0833
2
Fukui General Hospital
Fukui-shi, Fukui, Japan, 910-8561
3
Fukui Saiseikai Hospital
Fukui-shi, Fukui, Japan, 918-8503
4
University of Fukui Hospital
Iijima, Fukui, Japan, 910-1193