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| Sponsor: | Japan Clinical Oncology Group |
|---|---|
| Collaborators: |
Ministry of Health, Labour and Welfare, Japan Taiho Pharmaceutical Co., Ltd. Yakult Honsha Co., LTD |
| Information provided by: | Japan Clinical Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00142350 |
Purpose
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 |
|---|---|---|
|
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).
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 34 Study Locations| Study Chair: | Atsushi Ohtsu, MD | National Cancer Centr Hospital East |
More Information
| Study ID Numbers: | JCOG9912, C000000062 |
| Study First Received: | September 1, 2005 |
| Last Updated: | May 31, 2007 |
| ClinicalTrials.gov Identifier: | NCT00142350 History of Changes |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
gastric cancer 5-fluorouracil irinotecan |
cisplatin S-1 advanced or recurrent gastric cancer |
|
Antimetabolites Antimetabolites, Antineoplastic Digestive System Neoplasms Immunologic Factors Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Irinotecan Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Digestive System Diseases Stomach Diseases Radiation-Sensitizing Agents Cisplatin Stomach Neoplasms Fluorouracil Therapeutic Uses Gastrointestinal Neoplasms Antineoplastic Agents, Phytogenic |