SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Brain Metastases: an Interventional, Randomised, Multicentric Study
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 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 symptomatic brain metastases from solid tumors
详细描述
Standard treatment for brain metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (1800 cGy in 4 fractions of 450 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
- •symptomatic brain metastases from solid tumors
- •age > 18 years
- •ECOG performance status 0-3
- •no changes in supportive care in the week before radiotherapy
排除标准
- •pregnancy
- •previous 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 1800 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 initial symptoms after radiotherapy, assessed with Likert scale (weakness, motor disorders, cognitive impairment, personality changes, loss of balance, seizures, changes in speech, vision, hearing, memory problems, nausea or vomiting are evaluated as none-mild-moderate-severe)
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