NCT06165419招募中2 期
A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT
研究概览
简要总结
This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery
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
Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT
时间窗: 6 months
Assess the efficacy of spine SBRT alone in controlling spine metastases
次要结局
- Changes on EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire(1 months, 3 months, 6 months)
- Changes on Oswestry Low Back Disability Questionnaire(1 months, 3 months, 6 months)
- Changes on Neck Disability index(1 months, 3 months, 6 months)
- Progression-free survival(6 months)
- Reduction in epidural tumor volume(3 months)
- Overall survival(6 months)
研究者
Kartik Mani
Assistant Professor of Medicine
Stony Brook University
研究点 (2)
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