Randomized Phase III Study of 5-FU Continuous Infusion (5-FUci) Versus CPT-11 Plus CDDP (CP) Versus S-1 Alone (S-1) in Advanced Gastric Cancer (JCOG9912)
From the results of our previous phase III study (JCOG9205), continuous infusion of
5-fluorouracil has remained to be a control arm of this study. This study investigates the
superiority of a combination of irinotecan plus cisplatin and non-inferiority of S-1, a oral
fluoropyrimidine, compared to continuous infusion of 5-fluorouracil at the point of overall
survival, and the planned number of enrolled patients is 690 (230/arm).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
overall survival
Atsushi Ohtsu, MD
Study Chair
National Cancer Centr Hospital East
Japan: Ministry of Health, Labor and Welfare
JCOG9912
NCT00142350
November 2000
January 2007
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