A RAndomized Trial Comparing COnventional With STereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases (RACOST-trial)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 10
- 主要终点
- Pain reduction measured by the Dutch Brief Pain Inventory (BPI) questionnaire
研究概览
简要总结
A randomized, multicentre, phase III study comparing conventional radiotherapy (1x8Gy) with stereotactic radiotherapy (1x20Gy) for pain reduction and quality of life in spinal metastases.
详细描述
Study population: patients with painful spinal metastases from solid tumors without spinal cord compression or cord instability.
Objective
This study will test the hypothesis that stereotactic radiotherapy gives a better and longer lasting reduction of pain, local control and therewith a better quality of life. This in order to optimize and to individualize the treatment options for the patient.
Study design: Complaints due to pain will be analysed using the validated Dutch Brief Pain Inventory (BPI) and side-effects will be recorded using the Common Toxicity Criteria for Adverse Events (CTCAE). In addition to this the quality of life will be analysed using the EORTC QOL-C15-PAL and EORTC QLQ-BM22 questionnaires. For analysis of cost-effectiveness the EQ-5D will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •solid tumor with radiological diagnosis of spinal metastases
- •pain score minimum 2 on 11-point scale
- •maximum of 2 consecutive or noncontiguous spinal vertebra involved by tumor at current level of interest
- •No or mild neurological signs (radiculopathy, dermatomal sensory change and muscle strength of involved extremity)
- •Karnofsky performance ≥60
- •life expectancy > 6 weeks
- •non-pregnant, non-lactating female patients
排除标准
- •history of previous radiotherapy to the spine at current level of interest
- •spinal instability or neurological deficit
- •pathological fracture or impending fracture needing fixation
- •prior surgery to the spine at current level of interest
- •clinical signs of spinal cord compression or severe neurological deficits
- •patients with a pacemaker such that MRI cannot be performed or the treatment cannot be delivered safely
- •patients unable to undergo MRI
- •earlier nuclear medicine treatment
- •pregnancy
- •altered mental status that would prohibit the understanding and giving of informed consent
结局指标
主要结局
Pain reduction measured by the Dutch Brief Pain Inventory (BPI) questionnaire
时间窗: At six weeks since baseline
Pain is self-reported and measured by the validated Dutch Brief Pain Inventory (BPI) questionnaire
次要结局
- Comparison of time to pain response(pain response is calculated from the date of randomization at day 0-14, week 4, 6, and month 2, 3, 4, 6, 9, and 12)
- Duration of pain relief(Pain relief is calculated from the date of randomization at day 0-14, week 4, 6, and month 2, 3, 4, 6, 9, and 12)
- Toxicity measured by CTCAE 4.0 questionnaire(up to months 12)
- Quality of life(Quality of life is calculated from the date of randomization at day 0, 7, 14, week 4, 6, and month 2, 3, 4, 6, 9, and 12)