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Sponsors and Collaborators: |
Japan Clinical Oncology Group Japanese Ministry of Health, Labor and Welfare |
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Information provided by: | Japan Clinical Oncology Group |
ClinicalTrials.gov Identifier: | NCT00149201 |
To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis
Condition | Intervention | Phase |
---|---|---|
Gastric Cancer Neoplasm Metastasis |
Drug: 5-FU continuous infusion Drug: MTX + 5-FU sequential therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Phase III Study of 5-FU Continuous Infusion (5FUci) Versus MTX+5-FU Sequential Therapy (MF) in Gastric Cancer With Peritoneal Metastasis (JCOG0106-MF, MF/5FU) |
Estimated Enrollment: | 160 |
Study Start Date: | November 2002 |
Estimated Study Completion Date: | April 2008 |
Peritoneal metastasis is common in advanced gastric cancer and is considered an incurable disease state. Peritoneal metastasis may cause serious complications, such as intestinal obstruction, massive ascites, and hydronephrosis associated with the clinical presentation of abdominal pain and fullness, vomiting, constipation, malnutrition and renal dysfunction.5-FU continuous infusion remains the mainstay for chemotherapy against gastric cancer. On the other, sequential MTX+5-FU was reported to be effective in advanced gastric cancer with peritoneal metastasis in some phase II studies. Therefore, the randomized phase III study of 5-FU versus sequential MTX+5-FU in gastric cancer with peritoneal metastasis was conducted.
Ages Eligible for Study: | 20 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Kuniaki Shirao, MD,PhD | Gatrointestinal Oncology Division, National Cancer Center Hospital |
Study ID Numbers: | JCOG0106-MF, C000000123 |
Study First Received: | September 7, 2005 |
Last Updated: | May 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00149201 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
gastric cancer peritoneal metastasis randomized trial 5-FU MTX |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Fluorouracil |
Stomach Neoplasms Neoplasm Metastasis Gastrointestinal Neoplasms Stomach cancer |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses |