NIPH Clinical Trials Search

UMIN ID: UMIN000001858

Registered date:07/04/2009

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedgastric cancer
Date of first enrollment2008/10/01
Target sample size70
Countries of recruitmentJapan
Study typeInterventional
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


Primary Outcome1-year survival rate
Secondary OutcomeAdverse event rate, Progression free survival, Overall survival, Time to treatment failure

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteria1)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


public contact
Name Toshikazu Moriwaki
Address Japan
Affiliation University of Tsukuba Gastroenterology
scientific contact
Name Ichinosuke Hyodo
Address 2-1-1 Amakubo, Tsukuba-shi, Ibaraki-ken, Japan Japan
Affiliation University of Tsukuba Gastroenterology