NCT03947268已完成不适用
Palliative Short-course Radiotherapy in Advanced Pelvic Cancer: a Phase II Study (SHARON Project)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- Assessment of symptoms [pain]
研究概览
简要总结
The study wants to define the safety and efficacy of a short-course radiation therapy in patients with symptomatic advanced pelvic cancer.
详细描述
he study wants to define the safety and efficacy of a short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days for symptomatic palliation of advanced solid cancer.
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
- •histologically proven advanced pelvic cancer
- •excluded from curative therapy because of disease stage and/or presence of multiple comorbidities and/or poor performance status
- •age > 18 years
- •Eastern Cooperative Oncology Group (ECOG) <3
排除标准
- •prior radiotherapy to the same region
结局指标
主要结局
Assessment of symptoms [pain]
时间窗: 1 year]
Pain after treatment is evaluated with the Visual Analogic scale (VAS). Values range from 0 (no pain) to 10 (maximum possible pain).
次要结局
- Incidence of Treatment-Emergent Adverse Events [Acute radiation toxicity](1 year)
- Incidence of Treatment-Emergent Adverse Events [Late radiation toxicity](1 year)
- Assessment of the Quality of life (QOL)(1 year)
研究者
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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