NCT03455231已完成不适用
Short Course Accelerated Radiation Therapy (Sharon) in Complicated Bone Metastases Palliation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with complicated bone metastases.
详细描述
The study wants to define the maximum tolerated dose (MTD) of a conformal short course radiation treatment delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of complicated bone metastases.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •radiologically proven complicated bone metastasis
- •age > 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status < 3
排除标准
- •prior RT to the same region
结局指标
主要结局
Maximum tolerated dose
时间窗: 1 year
The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients
次要结局
- Quality of life(1 year)
- Pain relief(1 year)
- Acute toxicity(1 year)
- Late toxicity(1 year)
研究者
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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