Clinical Drug Experience Knowledgebase

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