NCT02590510Unknown4 期
Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis
Hui Bu0 个研究点目标入组 50 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 主要终点
- overall survival
研究概览
简要总结
The main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in the treatment of meningeal carcinomatosis.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 14 or more
- •a history of solid tumor
- •a new clinical neurological signs and symptoms
- •a typical CT(Computerized Tomography,CT) or MRI(Magnetic Resonance Imaging,MRI) imaging findings
- •tumor cells in cerebrospinal fluid
排除标准
- •KPS score <60
- •the tumor patients with organ failure
- •bacteria, fungi or viral meningitis
研究组 & 干预措施
The small dose of group
Experimental
The dose of methotrexate is 10 mg
干预措施: methotrexate (Drug)
The high dose of group
Active Comparator
The dose of methotrexate is 15 mg
干预措施: methotrexate (Drug)
结局指标
主要结局
overall survival
时间窗: one year
次要结局
- The incidence of adverse reactions(one year)
- KPS score(one year)
研究者
Hui Bu
Study Principal Investigator
Hebei Medical University
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