ACTRN12615001031550招募中2 期
A Phase II Study for the Treatment of Localised Spine Metastasis: Assessing the Safety and Efficacy of Image Guided Radiosurgery prior to Surgical Stabilisation.
Epworth HealthCare0 个研究点目标入组 20 人开始时间: 2015年10月1日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Males or females aged 18 to 85 (inclusive).
- •Histological diagnosis of a non-haematological malignancy.
- •Radiological (MRI or CT within 4 weeks) diagnosis of spinal metastases (C1-L5) who require surgery.
- •TOKUHASHI score of 9 or above.
- •Karnovsky performance score (KPS) > 70%.
- •Maximum involvement of two contiguous spinal levels.
- •Muscle power greater than 3/5.
- •Baseline NRPS greater or equal to 4 assessed within 36 hours prior to registration.
- •Ability to lie supine.
- •Women with child-bearing potential must have a negative serum pregnancy test and practice adequate contraception.
排除标准
- •Participants with rapidly progressive neurological symptoms.
- •Previous irradiation to the same spinal level.
- •Non-ambulatory status.
- •> 2 contiguous vertebral bodies involved.
- •> 2 treatment sites.
- •Predefined spinal cord tolerances cannot be met.
- •Chemotherapy or other systemic treatment <3 weeks prior to SBRT.
- •Taxane or Anthracycline containing chemotherapy < 4 weeks prior to, or concurrent with, SBRT.
- •Contraindications to radiological imaging and surgical intervention.
研究者
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