A Single Arm Phase II Study Assessing Efficacy of Stereotactic Radiosurgery (SRS) for Brain Metastasis (BM) From Small Cell Lung Cancer (SCLC)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 13
- 主要终点
- Overall survival
研究概览
简要总结
The purpose of the study is to see if stereotactic radiosurgery/SRS is an effective treatment for people with a new diagnosis of brain metastases from small cell lung cancer/SCLC.
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
- •Histologic diagnosis of small cell lung cancer
- •Radiographic diagnosis of up to 20 brain metastases on contrast-enhanced MRI
- •Age 18 and above
- •Performance status KPS 60-100/ECOG 0-2
- •Female patients must be of non-reproductive potential or have a negative serum pregnancy test at the time of enrollment
- •The patient or legally authorized representative is able to provide informed consent
排除标准
- •Unable to undergo contrast-enhanced MRI brain
- •Leptomeningeal disease confirmed on lumbar puncture, MRI brain, or MRI spine
- •Pregnant or lactating women
- •Prior brain-directed radiotherapy
- •Uncontrolled systemic disease without reasonable systemic therapy options felt likely to result in death as observed on CT or PET/CT imaging, no more than 3 months before study enrollment
研究组 & 干预措施
Participants with small cell lung cancer with brain metastases
Participants may be newly diagnosed small cell lung cancer with brain metastases at initial staging, or can alternatively be patients who develop brain metastases on therapy or during surveillance of systemic disease.
干预措施: Cerebrospinal fluid collection (Procedure)
Participants with small cell lung cancer with brain metastases
Participants may be newly diagnosed small cell lung cancer with brain metastases at initial staging, or can alternatively be patients who develop brain metastases on therapy or during surveillance of systemic disease.
干预措施: Stereotactic Radiosurgery (Radiation)
结局指标
主要结局
Overall survival
时间窗: 6 months
The primary endpoint of this study is the rate of overall survival at 6 months, with time measured from the start of SRS treatment. Participants will be censored at the date of last follow up or the last date the participant was known to be alive.
次要结局
未报告次要终点