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A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00142350
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : September 12, 2016
Sponsor:
Collaborators:
Ministry of Health, Labour and Welfare, Japan
Taiho Pharmaceutical Co., Ltd.
Yakult Honsha Co., LTD
Information provided by:
Japan Clinical Oncology Group

Study Description
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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

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

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 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).
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. overall survival

Secondary Outcome Measures :
  1. time to treatment failure
  2. incidences of adverse events
  3. response rate
  4. non-hospitalized survival

Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  1. unresectable or recurrent histologically proved gastric cancer
  2. adequate oral intake
  3. age 20 or older and 75 or younger
  4. Performance Status (ECOG):0, 1, 2
  5. measurable or unmeasurable lesions
  6. preserved organ functions
  7. no severe medical condition
  8. no prior chemotherapy for gastric cancer
  9. written informed consent

Exclusion Criteria:

  1. patient with marked infection or inflammation
  2. patient with severe peritoneal metastasis
  3. patient with massive pleural effusion
  4. patient with metastasis to CNS
  5. patient with diarrhea 4 or more times per day
  6. patient severe medical condition
  7. patient with other concurrent malignancy affecting on survival or adverse events
  8. pregnant or nursing patient or with intent to bear baby
  9. patient evaluated to be inadequate by a attending doctor
  10. patient requiring nutritional support
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Taiho Pharmaceutical Co., Ltd.
Yakult Honsha Co., LTD
Investigators
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Study Chair: Atsushi Ohtsu, MD National Cancer Centr Hospital East
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Japan Clinical Oncology Group:
gastric cancer
5-fluorouracil
irinotecan
 cisplatin
S-1
advanced or recurrent gastric cancer
Additional relevant MeSH terms:
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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