Radiotherapy of Motor Deficits From Metastatic Epidural Spinal Cord Compression (10 x 3 Gy Versus 5 x 4 Gy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 26
- 主要终点
- Number of Participants Showing Improvement or no Further Progression of Motor Deficits at 1 Month Following Radiotherapy
研究概览
简要总结
The primary aim of this randomized multi-center trial is to investigate the efficacy of the radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in patients with metastatic epidural spinal cord compression.
详细描述
The primary aim of this randomized multi-center trial is to investigate the efficacy of the radiotherapy regimens 5 x 4 Gy and 10 x 3 Gy with respect to the effect on motor function in patients with metastatic epidural spinal cord compression. The response rate (improvement in motor function or prevention of progression) will be assessed at one month following radiotherapy.
In addition, the following endpoints will be evaluated:
- Motor function; additional assessments directly and at 3 and at 6 months after radiotherapy
- Ability to walk; assessment directly and at 1, 3 and 6 months after radiotherapy
- Sensory function; assessment directly and at 1, 3 and 6 months after radiotherapy
- Quality of life; evaluation directly and at 1, 3 and 6 months after radiotherapy
- Pain assessment directly and at 1, 3 and 6 months after radiotherapy
- Overall survival up to 6 months following radiotherapy
- Local Progression-free survival up to 6 months following radiotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Motor deficits of the lower extremities resulting from metastatic epidural spinal cord compression, which have persisted for no longer than 30 days
- •Confirmation of diagnosis by magnetic resonance imaging (spinal computed tomography allowed)
- •Relatively poor survival prognosis (defined as ≤35 points on the survival score published in Cancer 2008)
- •Written informed consent
排除标准
- •Prior radiotherapy or surgery of the spinal areas affected by MESCC
- •History of symptomatic brain tumor or symptomatic brain metastases
- •Metastases of the cervical spine only
- •Other severe neurological disorders
- •Pregnancy, Lactation
- •Indication for decompressive surgery + stabilization of the affected spinal areas
结局指标
主要结局
Number of Participants Showing Improvement or no Further Progression of Motor Deficits at 1 Month Following Radiotherapy
时间窗: at 1 month following radiotherapy
Overall response was defined as improvement or no further progression of motor deficits following radiotherapy. Motor function was graded with the following 8-point scale: 0, complete paraplegia; 1, palpable or visible muscle contractions; 2, active movement of the leg without gravity; 3, active movement against gravity; 4, active movement against mild resistance; 5, active movement against intermediate resistance; 6, active movement against strong resistance; and 7, normal strength. Motor function was recorded separately for each leg resulting in total points of 0 to 14. Improvement of motor function was defined as an increase by at least 2 points compared to baseline. No further progression was defined as +/-1 point (i.e. +1 point, +/- 0 points or -1 point).
次要结局
- Number of Participants Who Were Alive at 6 Months Following Radiotherapy Without Deterioration of Motor Function During (or Directly Following) Radiotherapy and Freedom From In-field Recurrence of Metastatic Spinal Cord Compression Following Radiotherapy(6 months following radiotherapy)
- Number of Participants Who Experienced Relief of Distress at 1 Month Following Radiotherapy Compared to Baseline(at 1 month following radiotherapy)
- Number of Participants Who Were Able to Walk at 1 Month Following Radiotherapy(at 1 month following radiotherapy)
- Number of Participants Showing Improvement of Motor Deficits at 1 Month Following Radiotherapy(at 1 month following radiotherapy)
- Number of Participants Who Experienced Relief of Pain at 1 Month Following Radiotherapy Compared to Baseline(at 1 month following radiotherapy)
- Number of Participants Who Were Alive at 6 Months Following Radiotherapy(6 months following radiotherapy)
- Number of Participants Experiencing at Least One Grade >=2 Radiotherapy-related Toxicity(during radiotherapy and up to 6 months following radiotherapy)
研究者
Prof. Dirk Rades, MD
Prof. Dr. Dirk Rades. MD
University Hospital Schleswig-Holstein