NL-OMON42087已完成2 期
Stereotactic body radiotherapy followed by surgical stabilization for patients with painful unstable spinal metastases: First-in-man study according to the IDEAL recommendations - BLEND study
niversitair Medisch Centrum Utrecht0 个研究点目标入组 13 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Painful radiosensitive metastases from solid tumors in the thoracic or lumbar spine needing surgical stabilization
- •* Histologic proof of malignancy
- •* Radiographic evidence of spinal metastases
- •* Karnofsky performance status > 50
- •* Age > 18 years
- •* Written informed consent
排除标准
- •* Multiple spinal metastases necessitating bridging more than five vertebral levels during surgery
- •* Previous surgery or radiotherapy to index lesion
- •* SBRT cannot be delivered (Bilsky score 2 and 3 [Bilsky 2010])
- •* Neurological deficits (ASIA C, B or A)
- •* Partial neurological deficits (ASIA D) with rapid progression (hours to days)
- •* Inability to lie flat on table for SBRT
- •* Non-ambulatory patients
- •* Patient in hospice or with < 3 months life expectancy
- •* Medically inoperable or patient refused surgery
研究者
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