A Study of 5-FU Versus MTX+5-FU in Gastric Cancer With Peritoneal Metastasis
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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.
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Ages Eligible for Study:
20 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Massive pleural effusion
brain metastasis with symptoms
other severe medical conditions (infection, diabetes, hypertension, acute myocardial infarction, unstable angina, liver cirrhosis, intestinal pneumonia, pulmonary fibrosis)
Keywords provided by Japan Clinical Oncology Group:
randomized trial 5-FU
Additional relevant MeSH terms:
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Neoplasms, Second Primary
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases