Multicenter phase II study of S-1 plus Weekly Cisplatin in first-line treatment of unresectable or reccurent gastric cancer

UMIN ID: UMIN000001858

Registered date:07/04/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: gastric cancer
• Date of first enrollment: 2008/10/01
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

S-1 80mg/m2, day 1-14 Cisplatin 20mg/m2, day 1, 8 1 week rest
S-1 80mg/m2, day 1-21 Cisplatin 60mg/m2, day 8 2 week rest

Outcome(s)

• Primary Outcome: 1-year survival rate
• Secondary Outcome: Adverse event rate, Progression free survival, Overall survival, Time to treatment failure

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)Serious drug hypersensitivity or a history of drug allergy 2)Administered of flucytosine, phenytoin or warfarin potassium 3)Active infections 4)Serious complications (e.g., interstitial pneumonitis, pulmonary fibrosis, uncontrolled diabetes mellitus, renal failure or hepatic failure) 5)Uncontrolled watery diarrhea 6)Severe ascites or pleural effusion 7)Active double cancer 8)Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers 9)Men who are currently attempting to conceive children 10)Judged ineligible for participation in the study by the investigator for safety reasons

Related Information

• Primary Sponsor: Tsukuba Cancer Clinical Trial Group
• Secondary Sponsor: Tsukuba Cancer Clinical Trial Group
• Source(s) of Monetary Support: Ibaraki epidemiological research of cancer