NCT00904553已完成不适用
Pilot Study of Resection Combined With Stereotactic Radiosurgery in Patients With Limited (1-3) Brain Metastases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Determine toxicity of treatment with cranial SRS and resection
研究概览
简要总结
This study is to look more closely at the tumor removed during your surgery, and to follow your condition after your treatment.
The purpose of this study is to determine what side effects are common or more rare from this treatment, how well the treatment has worked for you, and to track whether you develop other brain metastases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patients must have a previously histopathologically proven diagnosis of malignancy.
- •Patients must be evaluated by Neurosurgery and Radiation Oncology
- •Patients must have 1-3 brain metastases seen on MRI or CT imaging. At least one brain metastases must be considered resectable by craniotomy as determined by the treating neurosurgeon. Brain lesion resection must be considered standard of care. A not uncommon situation is for a patient to undergo resection of a solitary metastasis, but prove to have more lesions on subsequent MRIs (perhaps too small to be seen on a pre-operative MRI). These patients will be eligible if the total number of lesions is 1-
- •All lesions must be treatable by SRS as determined by the treating neurosurgeon and radiation oncologist.
- •All lesions must be <4 cm in greatest dimension. For patients with more than 1 brain metastases, only 1 lesion can exceed 3 cm in greatest dimension.
- •In patients treated to the post-op surgical cavity, this cavity must be encompassed by a CTV of <5 cm.
- •Patients must have a Karnofsky performance status ≥
- •Extracranial disease must not be considered imminently life threatening (<2 month anticipated survival from extracranial disease).
- •Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
排除标准
- •life expectancy > 2 months
结局指标
主要结局
Determine toxicity of treatment with cranial SRS and resection
时间窗: During treatment and long term follow-up
Determine the local control of the treated lesion(s), distant brain control and overall patient survival.
时间窗: During treatment and long term follow-up
次要结局
- Tissue from the resected brain metastases will be evaluated with immunohistochemistry and/or comparative genomic hybridization to assess for potential markers for clinical outcome as well as potential markers of radiation response.(Following surgical resection)
研究者
Michael Milano, MD,PhD
Associate Professor
University of Rochester
研究点 (1)
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