Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord: Prospective Phase II Study
试验速览
- 阶段
- 2 期
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Neurologic response
研究概览
简要总结
Metastatic epidural spinal cord compression (MESCC) is a frequent oncologic emergency that requires to be treated promptly. Although direct decompressive surgery is the most effective treatment, surgery is only used in selected patients because most patients have a poor overall condition and short life expectancy. Radiation therapy (RT), therefore, is the most commonly used for patients with MESCC, but conventional RT alone can achieve modest neurologic outcomes.
The hypothesis to use stereotactic body radiation therapy (SBRT) for MESCC is that the rapid decompression of epidural mass, durable local control and subsequently improved neurologic outcomes compared to conventional RT are expected when MESCC is treated with SBRT.
详细描述
The definition of metastatic epidural spinal cord compression (MESCC)
- MESCC is defined as both an evidence of cord compression by radiologic evaluation and a manifestation of clinical feature at the level of cord compression.
- A cord compression by radiologic evaluation is defined as < 3mm gap between epidural mass and true spinal cord or indentation of thecal sac at the level of clinical feature by MRI.
- Clinical features include any or all of the followings: pain (local or radicular) or motor weakness or sensory change or incontinence.
Simulation -A Computed tomography (CT) scan will be acquired with the use of intravenous contrast and planning MRI will be also performed on the same day of simulation.
Spine SBRT
- One to four sessions of SBRT will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MESCC is present.
- •Localized spine metastases (C1 to L5 level); Maximum 3 separate sites and maximum 2 contiguous vertebral bodies
- •Performance state before the occurrence of neurologic symptoms : Eastern Cooperative Oncology Group 0-2
- •MRI within 2 weeks is mandatory
- •Paraspinal mass < 5cm in maximum dimension
- •Inoperable patients - refused or medically unfit for decompression surgery
- •life expectancy > 3 months
排除标准
- •Retropulsed bony fragment causing cord compression
- •Paraplegia ≥ 48 hours
- •Histology preferred to perform the chemotherapy as the first option (e.g. lymphoma, myeloma)
结局指标
主要结局
Neurologic response
时间窗: 1 month
* Neurologic response is defined as maintaining grade 4 or more motor power after completing SBRT or as an increase of motor power by at least 1 grade from the baseline motor power. * There should no decrease of motor power after completing SBRT. * The motor weakness is graded from 0 to 5 by Medical Research Council (MRC) scale.
次要结局
未报告次要终点
研究者
Doo Ho Choi
Professor, Department of Radiation Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Samsung Medical Center