Status:
COMPLETED
A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer
Lead Sponsor:
Japan Clinical Oncology Group
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Taiho Pharmaceutical Co., Ltd.
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
To 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
Detailed Description
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 combinat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
690 Patients enrolled
Trial Details
Trial ID
NCT00142350
Start Date
November 1 2000
End Date
January 1 2007
Last Update
September 12 2016
Active Locations (34)
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1
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, Japan, 464-8681
2
Nagoya Medical Center
Nagoya,Naka-ku,Sannomaru,4-1-1, Aichi-ken, Japan, 460-0001
3
Aichi Cancer Center,Aichi Hospital
Okazaki,Kake-machi,Kuriyado,18, Aichi-ken, Japan, 444-0011
4
Aomori Prefectural Central Hospital
Higashitsukurimiti,2-1-1,Aomori, Aomori, Japan, 030-0911