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A Study of 5-FU Versus MTX+5-FU in Gastric Cancer With Peritoneal Metastasis
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Japan Clinical Oncology Group
Japanese Ministry of Health, Labor and Welfare
Information provided by: Japan Clinical Oncology Group
ClinicalTrials.gov Identifier: NCT00149201
  Purpose

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

MedlinePlus related topics: Cancer Stomach Cancer
Drug Information available for: Fluorouracil
U.S. FDA Resources
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)

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • overall survival

Secondary Outcome Measures:
  • oral intake
  • toxicity

Estimated Enrollment: 160
Study Start Date: November 2002
Estimated Study Completion Date: April 2008
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. histologic confirmation of gastric adenocarcinoma
  2. inoperable metastatic disease or recurrent metastatic disease after surgery
  3. disease with peritoneal metastasis
  4. 20 years or more but less than 75 years
  5. performance status 2 or less on the Eastern Cooperative Oncology Group scale
  6. no prior treatment for gastric carcinoma except for surgery and adjuvant chemotherapy
  7. no prior chemotherapy or radiotherapy for other disease except for gastric cancer
  8. adequate bone marrow function, adequate liver function, and adequate renal function
  9. no prior transfusion for anemia
  10. provision of written informed consent

Exclusion Criteria:

  1. Massive pleural effusion
  2. brain metastasis with symptoms
  3. severe diarrhea
  4. other severe medical conditions (infection, diabetes, hypertension, acute myocardial infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary fibrosis)
  5. other active malignancies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149201

  Show 34 Study Locations
Sponsors and Collaborators
Japan Clinical Oncology Group
Japanese Ministry of Health, Labor and Welfare
Investigators
Study Chair: Kuniaki Shirao, MD,PhD Gatrointestinal Oncology Division, National Cancer Center Hospital
  More Information

Related Info  This link exits the ClinicalTrials.gov site

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

Keywords provided by Japan Clinical Oncology Group:
gastric cancer
peritoneal metastasis
randomized trial
5-FU
MTX

Study placed in the following topic categories:
Stomach Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Fluorouracil
Stomach Neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Stomach cancer

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009