Randomized phase III study of TS-1 alone versus TS-1 plus Lentinan(LNT) in advanced or recurrent gastric cancer (AGC)

INTERVENTION: TS‐1 alone : TS‐1 is administered orally at the dose of 80mg/m2/day for 28 days, followed by 14 days rest. TS‐1+ Lentinan : TS‐1 is administered orally at the dose of 80mg/m2/day for 28 days, followed by 14 days rest, and lentinan is administered intravenously at the dose of 2mg in a week. CONDITION: Advanced or recurrent gastric cancer (AGC) PRIMARY OUTCOME: overall survival SECONDARY OUTCOME: TTF, adverse events, QOL, tumor response INCLUSION CRITERIA: 1) Histologically demonstrated adenocarcinoma of advanced or recurrent gastric carcinoma 2) If measurable lesions exist, these have to be evaluated within 28 days before registration 3) No prior therapy 4) Sufficient organ functions 5) Performance Status (ECOG scale) : 0‐2 6) Expected survival over 3 months 7) Oral intake is possible 8) Written informed consent