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A Study of 5-FUci Versus CPT-11 Plus CDDP Versus S-1 Alone in Advanced Gastric Cancer
This study has been completed.
First Received: September 1, 2005   Last Updated: May 31, 2007   History of Changes
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)

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • overall survival

Secondary Outcome Measures:
  • time to treatment failure
  • incidences of adverse events
  • response rate
  • non-hospitalized survival

Estimated Enrollment: 690
Study Start Date: November 2000
Estimated Study Completion Date: January 2007
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).

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142350

  Show 34 Study Locations
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Taiho Pharmaceutical Co., Ltd.
Yakult Honsha Co., LTD
Investigators
Study Chair: Atsushi Ohtsu, MD National Cancer Centr Hospital East
  More Information

Additional Information:
No publications provided by Japan Clinical Oncology Group

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
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

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010