A Study For Using Radiosurgery On Limited Metastases
A Pilot Study For Using Radiosurgery On Limited Metastases
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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Rochester、New York、美国、14642
- University of Rochester Department of Radiation Oncology
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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:
Age ≥ 18 years
KPS ≥ 70
Palliative: Disease most likely to be life limiting, is definable, and treatable to a sterilizing dose according to protocol criteria.
The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol
Previously treated lesions are not eligible unless the prescribed dose can be safely delivered. Previously enrolled patients can be retreated to new lesions if they still meet protocol requirements.
Informed consent must be obtained.
Pregnancy test must be negative for women of child bearing potential.
Out of state patients are eligible, if communication with the referring physicians is expected to be adequate to address the primary aim. The secondary aim (blood cytokines) is optional for out-of-state patients.
Exclusion Criteria:
Technical inability to achieve required dose based on safe dose constraints required for radiosurgery
Women who are pregnant or nursing..
Failure to meet inclusion requirements
Contraindications to radiation.
Patient should not be eligible for primary disease specific radiosurgical protocols
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：立体定向放射治疗
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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 |
|---|---|---|
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Percentage of Curatively Treated Patients With Progression-free Survival
大体时间：24 months
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Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.
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24 months
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Percentage of Palliatively Treated Patients With Progression-free Survival
大体时间：24 months
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Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease.
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24 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles
大体时间：30 months from date of registration.
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Correlation of data from QOL questionnaires and blood markers.
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30 months from date of registration.
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Analyze Impact of Disease Bulk and Number of Sites Involved.
大体时间：From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years
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Analysis or response and progression.
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From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years
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合作者和调查者
调查人员
- 首席研究员：Michael Milano, MD PhD、University of Rochester
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
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 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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