A Pilot Study For Using Radiosurgery On Limited Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Percentage of Curatively Treated Patients With Progression-free Survival
研究概览
简要总结
The standard therapy in cases such as yours is surgery, radiation therapy, chemotherapy or hormonal therapy alone or in combination. The main purpose of this study is to evaluate whether radiosurgery alone affects your quality and length of life. A second purpose of this study is to determine if the levels of special types of protein (called cytokines) found in the blood are related to your quality of life during your course of treatment and follow-up.
详细描述
In this research study high dose stereotactic body radiation therapy will be directed at the site of metastasis. This treatment will be given once a day, 5 times a week (Monday through Friday) for one to four weeks depending on the location and size of the disease to be treated. Blood for the cytokine tests will be drawn before your therapy starts, weekly during therapy and at the follow-up visits as stated in the next paragraphs. Two to four tablespoons of blood will be removed each time.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •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.
排除标准
- •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
研究组 & 干预措施
Stereotactic body radiation therapy
干预措施: Stereotactic Body Radiation Therapy (Procedure)
结局指标
主要结局
Percentage of Curatively Treated Patients With Progression-free Survival
时间窗: 24 months
Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.
Percentage of Palliatively Treated Patients With Progression-free Survival
时间窗: 24 months
Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease.
次要结局
- Analyze Impact of Disease Bulk and Number of Sites Involved.(From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years)
- Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles(30 months from date of registration.)
研究者
Michael Milano, MD,PhD
Associate Professor
University of Rochester