NCT01594892已完成不适用
Dose-intensified Image-Guided Fractionated Radiosurgery for Spinal Metastases (DOSIS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Number of patients, in whom pain is decreased in response to treatment
研究概览
简要总结
It is the study hypothesis that hypo-fractionated image-guided radiosurgery significantly improves pain relief compared to historic data of conventionally fractionated radiotherapy. Primary endpoint is pain response 3 months after radiosurgery, which is defined as pain reduction of ≥2 points at the treated vertebral site on the 0 to 10 Visual Analogue Scale. 60 patients will be included into this II trial.
详细描述
The current study will investigate efficacy and safety of radiosurgery for painful vertebral metastases and three characteristics will distinguish this study.
- A prognostic score for overall survival will be used for selection of patients with longer life expectancy to allow for analysis of long-term efficacy and safety.
- Fractionated radiosurgery will be performed with the number of treatment fractions adjusted to either good (10 fractions) or intermediate (5 fractions) life expectancy. Fractionation will allow inclusion of tumors immediately abutting the spinal cord due to higher biological effective doses at the tumor - spinal cord interface compared to single fraction treatment.
- Dose intensification will be performed in the involved parts of the vertebrae only, while uninvolved parts are treated with conventional doses using the simultaneous integrated boost concept.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established histological diagnosis of a malignant tumour (primary or metastatic)
- •Vertebral metastasis confirmed via biopsy or radiology
- •Pain in the involved spinal region or free of pain under pain medication
- •Fully consenting patients, >18 years old
- •Karnofsky Performance Index ≥60%
- •Good or intermediate life expectancy according to the modified prognostic Mizumoto Score (score ≤ 9)
- •Patient must be able to tolerate fixation systems and 30 minutes treatment time
- •Discussed in interdisciplinary tumour board
- •The following types of spinal tumours are eligible:
- •Recurrent / residual tumours after surgery
- •Tumours in medically inoperable patients or patients deemed inoperable due to limited life expectancy / tumour load
- •Lesions associated with significant surgical risk
排除标准
- •Short life expectancy according to the modified Mizumoto Sore
- •"Radiosensitive" histologies (i.e. lymphoma, SCLC, multiple myeloma)
- •Non-ambulatory status
- •Progressive neurological symptoms/deficit
- •> 3 involved vertebral levels
- •> 2 treatment sites
- •Spine instability
- •Previous radiotherapy at the involved levels
结局指标
主要结局
Number of patients, in whom pain is decreased in response to treatment
时间窗: Change in pain from baseline to 3 months post-treatment
Decrease in pain by ≥2 points at the treated vertebral site on the 0 (no pain) to 10 (the severest pain) Visual Analogue Scale without analgesic increase
次要结局
- Patient-assessed 5 dimensions of patient's quality-of-life(Changes in quality of life from baseline to 3 months post-treatment)
- Patient-assessed overall health status(Changes in quality of life from baseline to 3 months post-treatment)
- Overall survival(2 years)
- Number of patients developing acute toxicity(Changes from baseline up to 6 weeks post-treatment)
- Number of patients developing late toxicity(Changes from >6weeks up to 2 years post-treatment)
- Local tumor control(2 years)
研究者
研究点 (7)
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