NIPH Clinical Trials Search

UMIN ID: UMIN000000574

Registered date:20/01/2007

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedAdvanced or recurrent gastric cancer (AGC)
Date of first enrollment2007/02/01
Target sample size300
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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.


Primary Outcomeoverall survival
Secondary OutcomeTTF, adverse events, QOL, tumor response

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria1) 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
Exclude criteria1) Limitation of use of TS-1 or Lentinan 2) Infection and inflammation 3) Serious heart disease 4) Serious coexisting illness 5) A large amount of pleural effusion or peritoneal fluid 6) Broad bone metastasis 7) Brain metastasis 8) Fresh bleeding from digestive organs 9) Diarrhea 10) Severe mental disorders 11) Active synchronous malignancy 12) Pregnant or nursing 13) Not suitable for participating in this study for any other reason

Related Information


public contact
Name Japanese Foundation for Multidisciplinary Treatment of Cancer
Address TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan Japan
Telephone 03-5627-7594
Affiliation Japanese Foundation for Multidisciplinary Treatment of Cancer Office
scientific contact
Name Masaaki Oka
Address 1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan Japan
Affiliation Yamaguchi University Graduate School of Medicine Department of Digestive Surgery and Surgical Oncology