Randomized Controlled Study of Postoperative Adjuvant Therapy for Gastric Cancer Using TS-1 or TS-1+PSK

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hokuriku-Kinki Immunochemotherapy Study Group
• Treatments: Krestin; polysaccharide-K; Tegafur

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