A randomized phase III trial of postoperative adjuvant oral fluoropyrimidine vs. sequential paclitaxel / oral fluoropyrimidine; and UFT vs. S1 for T3 / T4 gastric carcinoma: the Stomach Cancer Adjuvant Multi-institutional Trial Group (SAMIT) Trial

UMIN ID: C000000082

Registered date:01/09/2005

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Gastric Cancer
• Date of first enrollment: 2004/08/01
• Target sample size: 1480
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

UFT alone UFT 267 mg/m2/day daily for 4 weeks, every 4 weeks x6
S1 alone(control) S1 80 mg/m2/day daily for 2 weeks, every 3 weeks x8
Paclitaxel- UFT sequential Paclitaxel 80 mg/m2 Day 1, 8 for the first 3 weeks, Day 1, 8, 15 every 4 weeks; 14 day interval UFT 267 mg/m2/day daily for 4 weeks, every 4 weeks x3
Paclitaxel- TS-1 sequential Paclitaxel 80 mg/m2 Day 1, 8 for the first 3 weeks, Day 1, 8, 15 every 4 weeks; 14 day interval S1 80 mg/m2/day daily for 2 weeks, every 3 weeks x4

Outcome(s)

• Primary Outcome: Disease- free survival
• Secondary Outcome: Incidence of adverse events, overall survival and proportion of patients who completed the protocol treatment.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Serious complications including ischemic heart disease and arrhythmia which require treatment History of myocardial infarction in 6 months Liver disease under treatment Pneumonitis or lung fibrosis in need for oxygen therapy Gastrointestinal bleeding in need for repeated blood transfusion Psychological disease which require treatment Diabetes mellitus under treatment Bowel obstruction or ileus Medical history of allergy or hypersensitivity to any drugs Hypersensitivity to Cremophor EL Acute inflammation Pregnancy Synchronous malignancies that may affect survival or adverse events Patients judged inappropriate for the study by the physicians

Related Information

• Primary Sponsor: Young Leaders' Program (YLP), Nagoya University School of Medicine
• Secondary Sponsor: EBM Cooperative Research Center, Kyoto University
• Source(s) of Monetary Support: Epidemiological and Clinical Research Information Network (ECRIN)