NCT00634426已完成不适用
Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression. Quality of Life and Cost-effectiveness Outcomes
AOSpine North America Research Network10 个研究点 分布在 2 个国家目标入组 163 人开始时间: 2008年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 10
- 主要终点
- Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory
研究概览
简要总结
The aim of this trial is to evaluate the differences in pain relief, neurological function, quality of life and survival in patients with metastatic epidural spinal cord compression (MESCC) who are managed with a combination of surgery and radiotherapy versus radiotherapy alone.
Further we shall evaluate cost-effectiveness of the two treatment approaches.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Single symptomatic metastatic epidural spinal compression at any level confirmed by MRI
- •Age 18 and more
- •Able and willing to give written informed consent to participate in the study
- •Able to read and write English on an elementary level
排除标准
- •Multiple symptomatic spinal metastases
- •Radiosensitive tumors
- •Radioresistant tumors
- •Primary cancer site in CNS or spine
- •Poor life expectancy (< 3 months)
- •Patients with a tumor that has compressed only the cauda equina or spinal roots
- •Has a recent history of substance abuse
- •Is a prisoner
- •Currently involved in another study
- •has a disease or condition that would preclude accurate evaluation
结局指标
主要结局
Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory
时间窗: 6 weeks / 3, 6, 9, 12, 18, 24 months
Neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination
时间窗: 24 months
次要结局
- Survival(24 months)
- SF-36 v2(24 month)
- EQ-5D(24 months)
- Oswestry Disability Index (ODI)(24 months)
- Caregiver Activity Survey(24 months)
- Adverse events(24 months)
研究者
研究点 (10)
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