NCT04178343已完成不适用
Tomotherapy for Leptomeningeal Metastases: a Single Arm, Single Center, Phase II Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for leptomeningeal metastases.
详细描述
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy for leptomeningeal metastases, which are defined as leptomeningeal metastases with or without brain metatstases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of primary tumor and conformed meningeal metastases by enhanced MRI; KPS ≥60,or KPS ≥40 and the limitation of motion is simply caused by brain tumor that is adjacent to the motor function areas; Age: 18-75 years old; Adequate organ function:WBC≥4.0x109/L Neu ≥ 1.5x109/L Hemoglobin ≥ 110 g/L Platelets ≥100 x109/L Total bilirubin ≤ 1.5x ULN AST and ALT ≤ 1.5x ULN BUN and Cr: within the normal range.
排除标准
- •Other clinically significant diseases (e.g.myocardial infarction within the past 6 months, severe arrhythmia); unable or unwilling to comply with the study protocol; patients who are anticipated in other clinical trials of meningeal metastases; pregnant patients or female patients whose HCG is positive; unsuitable to participate in study, that in the opinion of the treating physician.
结局指标
主要结局
overall survival
时间窗: up to 2 years
the time from radiation to death
次要结局
- progress free survival rate(up to 1 year)
- local control(up to 1 year)
- adverse event(up to 2 years)
- intracranial progress free survival(up to 1 year)
研究者
Jianping Xiao
Dr
Chinese Academy of Medical Sciences
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Tomotherapy for Refractory Brain MetastasesBrain MetastasesNCT03027544Chinese Academy of Medical Sciences150
Enrolling By Invitation
不适用
Retrospective Study on Leptomeningeal Metastasis of Solid TumorsLeptomeningeal MetastasisNCT06705049Shanghai Zhongshan Hospital107
招募中
不适用
Intra-pemetrexed Alone or Combined With Concurrent Radiotherapy for Leptomeningeal MetastasisLeptomeningeal MetastasisNCT05305885The First Hospital of Jilin University100
已完成
1 期
Intrathecal Pemetrexed for Leptomeningeal MetastasisLeptomeningeal MetastasesNCT05289908The First Hospital of Jilin University34
招募中
不适用
Proton Cranio-spinal Irradiation for Leptomeningeal MetastasisLeptomeningeal MetastasisNCT05746754University of Aarhus50