A Study of 5-FU Versus MTX+5-FU in Gastric Cancer With Peritoneal Metastasis

Study Overview
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Brief Summary
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To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis

Detailed Description
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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.

Official Title
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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)

Conditions
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Gastric Cancer, Neoplasm Metastasis

Intervention / Treatment
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* Drug: 5-FU continuous infusion
* Drug: MTX + 5-FU sequential therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologic confirmation of gastric adenocarcinoma inoperable metastatic disease or recurrent metastatic disease after surgery disease with peritoneal metastasis 20 years or more but less than 75 years performance status 2 or less on the Eastern Cooperative Oncology Group scale no prior treatment for gastric carcinoma except for surgery and adjuvant chemotherapy no prior chemotherapy or radiotherapy for other disease except for gastric cancer adequate bone marrow function, adequate liver function, and adequate renal function no prior transfusion for anemia provision of written informed consent Exclusion Criteria: Massive pleural effusion brain metastasis with symptoms severe diarrhea other severe medical conditions (infection, diabetes, hypertension, acute myocardial infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary fibrosis) other active malignancies

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 5-FU continuous infusion|nan|
|Drug: MTX + 5-FU sequential therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oral intake |  |  | 
| toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, peritoneal metastasis, randomized trial, 5-FU, MTX