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Sponsors and Collaborators: |
Japan Clinical Oncology Group Japanese Ministry of Health, Labor and Welfare Taiho Pharmaceutical Co., Ltd. Yakult Honsha Co., LTD |
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Information provided by: | Japan Clinical Oncology Group |
ClinicalTrials.gov Identifier: | NCT00142350 |
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
Condition | Intervention | Phase |
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Gastric Cancer |
Drug: continuous infusion of 5-fluorouracil Drug: combination of irinotecan and cisplatin Drug: oral administration of S-1 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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) |
Estimated Enrollment: | 690 |
Study Start Date: | November 2000 |
Estimated Study Completion Date: | January 2007 |
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).
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Atsushi Ohtsu, MD | National Cancer Centr Hospital East |
Study ID Numbers: | JCOG9912, C000000062 |
Study First Received: | September 1, 2005 |
Last Updated: | May 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00142350 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
gastric cancer 5-fluorouracil irinotecan |
cisplatin S-1 advanced or recurrent gastric cancer |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Cisplatin Gastrointestinal Diseases Fluorouracil |
Stomach Neoplasms Irinotecan Gastrointestinal Neoplasms Stomach cancer Recurrence |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Antineoplastic Agents, Phytogenic |