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临床试验/NCT00149201
NCT00149201已完成3 期

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)

Japan Clinical Oncology Group68 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2002年11月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
160
试验地点
68
主要终点
overall survival

研究概览

简要总结

To develop effective chemotherapy regimen against gastric cancer with peritoneal metastasis

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

overall survival

次要结局

  • toxicity
  • oral intake

研究者

申办方类型
Other

研究点 (68)

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