Title
A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer
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)
Phase
Phase 3Lead Sponsor
Japan Clinical Oncology GroupStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Gastric CancerIntervention/Treatment
irinotecan fluorouracil s-1 gimeracil oteracil cisplatin tegafur ...Study Participants
690To investigate the superiority of a combination of irinotecan and cisplatin and the non-inferiority of S-1 compared to continuous infusion of 5-FU in advanced gastric cancer
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).
Inclusion Criteria: unresectable or recurrent histologically proved gastric cancer adequate oral intake age 20 or older and 75 or younger Performance Status (ECOG):0, 1, 2 measurable or unmeasurable lesions preserved organ functions no severe medical condition no prior chemotherapy for gastric cancer written informed consent Exclusion Criteria: patient with marked infection or inflammation patient with severe peritoneal metastasis patient with massive pleural effusion patient with metastasis to CNS patient with diarrhea 4 or more times per day patient severe medical condition patient with other concurrent malignancy affecting on survival or adverse events pregnant or nursing patient or with intent to bear baby patient evaluated to be inadequate by a attending doctor patient requiring nutritional support
