SHort Course Accelerated RadiatiON Therapy (SHARON) in Complicated Bone Metastases Palliation: an Interventional, Randomised, Multicentric Study
试验速览
- 阶段
- 不适用
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Efficacy of palliation using the short course scheme compared with the standard scheme
研究概览
简要总结
Aim of the study is to assess efficacy of a short course radiation treatment in patients with complicated bone metastases
详细描述
Standard treatment for complicated bone metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (4000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •complicated bone metastases from any solid tumor
- •age >18 years
- •ECOG performance status 0-3
- •symptomatic lesion (NRS >1)
- •no changes in analgesic treatment at least in the week before radiotherapy
排除标准
- •pregnancy
- •previously irradiation of the same region
研究组 & 干预措施
standard treatment
Patients in this group are treated with 3000 cGy in 10 daily fractions
干预措施: standard treatment (Radiation)
short course treatment
Patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)
干预措施: short course treatment (Radiation)
结局指标
主要结局
Efficacy of palliation using the short course scheme compared with the standard scheme
时间窗: 3 months
Reduction of pain after radiotherapy, assessed with VAS (visual analogue scale)
次要结局
- Acute toxicity in the two treatment groups(3 months)
- Late toxicity in the two treatment groups(12 months)
- Quality of Life (QoL) assessment in the two groups(12 months)
研究者
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna