Study of TS-1 or TS-1 + PSK for Gastric Cancer Patients

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Since it is not uncertain about efficacy of combination therapy with PSK and TS-1 in gastric cancer, in this study, we compare efficacy and safety of postoperative adjuvant therapy using TS-1 or TS-1+PSK in the stage II or III gastric cancer patients.

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

Details

• Lead Sponsor: Tokyo Metropolitan Oncology Group
• Treatments: Krestin; polysaccharide-K; Tegafur

Criteria

Inclusion Criteria:

• Patient who is pathologically confirmed as gastric cancer

• Patient who has received surgery with D2 or more lymph node dissection and whose final curability of surgical resection is grade A or B

• Patient whose final stage is II (except for T1), IIIA, or IIIB

• Patient without liver, peritoneal and distant metastasis, and who is negative in peritoneal cytological diagnosis

• Patient whose age at the registration is ranging between 20 and 80 years old

• Patient who has not received any preoperative therapy including radiotherapy, chemotherapy and immunotherapy

• Patient who has received surgery for gastric cancer within six weeks before the registration, and is judged to be capable of oral administration

• Patient who has no serious concurrent complications, and satisfies the following criteria

• White blood cell count: > LLN or > 4,000 /mm3

• Platelet count: > 100,000 /mm3

• Serum total bilirubin: < 1.5 mg/dL

• Serum AST (GOT), ALT (GPT): < 2.5 * ULN

• Serum creatinine: < ULN

• Patient who has received an explanation of this study by assent documents, and has given written informed consent to participate in this study

Exclusion Criteria:

• Patient with metachronous or synchronous multicancer

• Patient who contraindicates to TS-1

• Patient who requires continuous use of flucytosine, phenytoin or warfarin potassium

• Patient who has experienced serious drug allergy over grade 3 in the past

• Patient with serious complications including paralysis of intestine, ileus, interstitial pneumonitis, fibroid lung, uncontrollable diabetes mellitus, heart insufficiency, renal insufficiency or hepatic insufficiency

• Patient with diarrhea (watery stool)

• Patient who is pregnant or in lactation, or wish to become pregnant during this study

• Male patient who intends to make someone pregnant during this study

• Patient with HIV positive

• Patient who is judged to be inappropriate as subject to this study by the principal investigator or the doctors in charge