Tomotherapy for Refractory Brain Metastases (TRBM)
Tomotherapy for Refractory Brain Metastases: a Single Arm, Single Center Phase II Trial
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国、100021
- 招聘中
- Chinese Academy of Medical Sciences
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接触:
- Jianping Xiao
- 电话号码:86-13811026919
- 邮箱:jpxiao8@163.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
• 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:experimental arm
Group A: multiple brain metastases: no less than 3 lesions in the brain Group B: Large Brain Metastases: the volume of lesion is no smaller than 6cc or the maximum diameter of the lesion is no shorter than 3cm Group C:Meningeal Metastases. Intervention:tomotherapy |
Tomotherapy: The regular fraction modes were as follows: a. lesions≥3 cm:52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions<2cm:36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm: 40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem:50-60Gy/2.5-3Gy/20f; 3. multiple lesions with large lesion: whole brain radiation (WBRT) with 40Gy/2Gy/20f and concurrent boost of 60Gy/3Gy/20f of the lesions. TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Objective response rate
大体时间:2-3 months after radiation
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Using RTOG9508 criteria, Tumor control is defined as CR+PR+SD
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2-3 months after radiation
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
无进展生存率
大体时间:长达 1 年
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长达 1 年
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局部控制率
大体时间:长达 1 年
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长达 1 年
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Overall survival rate
大体时间:up to 3 years
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up to 3 years
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intracranial progress free survival rate
大体时间:up to 1 year
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up to 1 year
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adverse event
大体时间:from the day of radiation, up to 6 months
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from the day of radiation, up to 6 months
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cause of death
大体时间:from the day of radiation to death date, up to 5 years
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from the day of radiation to death date, up to 5 years
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合作者和调查者
调查人员
- 首席研究员:Jianping Xiao、Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- NCC2014 YZ-14
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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