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

UMIN ID: UMIN000000574

Registered date:20/01/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced or recurrent gastric cancer (AGC)
• Date of first enrollment: 2007/02/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: TTF, adverse events, QOL, tumor response

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female

Include 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

Exclude criteria

1) 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

• Primary Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer
• Source(s) of Monetary Support: Japanese Foundation for Multidisciplinary Treatment of Cancer