NCT03027544Unknown不适用
Tomotherapy for Refractory Brain Metastases: a Single Arm, Single Center Phase II Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This clinical trial was designed to investigate the efficiency and toxicity of tomotherapy for refractory brain metastases.
详细描述
This is a single-arm, single center, phase II trial to investigate the feasibility and toxicity of tomotherapy for refractory brain metastases, which are defined as A: multiple brain metastases(≥3 lesions); B: large brain metastases(with one lesion's volume is no smaller than 6cc or the longest diameter is no shorter than 3cm); C: meningeal metastases.
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 brain metastases by enhanced MRI or CT; the lesion number is no less than 3; or the tumor volume is no smaller than 6cc; or tumor diameter is no shorter than 3cm; or uncontrolled brain tumor after whole brain radiotherapy(WBRT); or the tumor is adjacent to essential structures of the brain, such as brain stem, optic chiasma, optic tract, etc; 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 end-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.
- •The expected survival time is less than 3 months.
- •Patients who are anticipated in other clinical trials of brain metastases.
- •Patients who has been treated with SRT in other hospitals
- •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
Objective response rate
时间窗: 2-3 months after radiation
Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD
次要结局
- Overall survival rate(up to 3 years)
- progress free survival rate(up to 1 year)
- local control rate(up to 1 year)
- intracranial progress free survival rate(up to 1 year)
- adverse event(from the day of radiation, up to 6 months)
- cause of death(from the day of radiation to death date, up to 5 years)
研究者
Jianping Xiao
Dr
Chinese Academy of Medical Sciences
研究点 (1)
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