A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer
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ClinicalTrials.gov Identifier: NCT00142350 |
Recruitment Status :
Completed
First Posted : September 2, 2005
Last Update Posted : September 12, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer | Drug: continuous infusion of 5-fluorouracil Drug: combination of irinotecan and cisplatin Drug: oral administration of S-1 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 690 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Study Start Date : | November 2000 |
Study Completion Date : | January 2007 |
- overall survival
- time to treatment failure
- incidences of adverse events
- response rate
- non-hospitalized survival
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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142350
Study Chair: | Atsushi Ohtsu, MD | National Cancer Centr Hospital East |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00142350 |
Other Study ID Numbers: |
JCOG9912 C000000062 |
First Posted: | September 2, 2005 Key Record Dates |
Last Update Posted: | September 12, 2016 |
Last Verified: | September 2016 |
gastric cancer 5-fluorouracil irinotecan |
cisplatin S-1 advanced or recurrent gastric cancer |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Fluorouracil Irinotecan |
Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |