Phase II Single-arm Study of Pre-operative Stereotactic Radiosurgery for Brain Metastases.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)
研究概览
简要总结
RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.
详细描述
OBJECTIVES:
Primary
- To estimate the rate of recurrence at the surgical site in patients with brain metastases treated with neoadjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgical resection and whole-brain radiotherapy (WBRT).
Secondary
- To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with neoadjuvant SRS alone.
- To determine the volume of adjacent normal brain parenchyma irradiated in these patients.
- To estimate the rate of new brain metastases outside of the neoadjuvant SRS site in these patients.
- To estimate the quality of life of these patients after neoadjuvant SRS alone.
- To assess the effect of SRS and surgical intervention on the preservation of neurocognitive functioning in these patients.
- To determine the clinical significance (mass effect, cognitive functioning, and other symptoms) of locally recurrent brain metastases at the time of their occurrence in these patients.
- To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease, in these patients.
- To estimate the overall survival of these patients.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of Patients With Local Recurrence at the Surgical Site Within 12 Months After Stereotactic Radiosurgery (SRS)
时间窗: Within 12 months after SRS
Number of patients with local recurrence at the surgical site within 12 months after stereotactic radiosurgery (SRS) as measured by magnetic resonance imaging (MRI). To determine local recurrence, we evaluated follow-up MRI's for reappearance of a lesion in exactly the same site in the brain as the first lesion(s).
次要结局
- Volume of Adjacent Normal Brain Parenchyma Irradiated(At time of SRS)
- Number of Patients With New Brain Metastases Outside of the Pre-operative Stereotactic Radiosurgery (SRS) Site(Within 24 months post-SRS)
- Clinical Significance of Locally Recurrent Brain Metastases(24 months post-SRS)
- Quality of Life After Stereotactic Radiosurgery (SRS) as Measured by the Functional Assessment of Cancer Therapy-Brain (FACT-Br)(Administered at baseline and every 3 months post-SRS)
- Preservation of Neurocognitive Functioning as Measure by the Mini-Mental State Exam (MMSE)(Administered at baseline and every 3 months post-SRS)
- Number of Patients Receiving Salvage Whole-brain Radiotherapy, Stereotactic Radiosurgery (SRS), or Surgery(Within 24 months post-SRS)
- Number of Patients Who Died Due to Neurological Causes(Within 24 months post-SRS)
- Overall Survival (OS)(24 months after SRS)