SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Pelvic Cancer: an Interventional, Randomized, Multicentric Study
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- efficacy of palliation using the short course scheme compared with the standard scheme: Likert scale
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 pelvic malignant lesions
详细描述
standard treatment for pelvic lesions (300 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 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
- •symptomatic pelvic malignant lesions (primary solid tumors or metastases from solid tumor)
- •age > 18 years
- •Eastern Cooperative Oncology Group (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 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: Likert scale
时间窗: 3 months
reduction of initial symptoms after radiotherapy, assessed with Likert scale (pain, bleeding, diarrhoea, bowel obstruction, polyuria, urinary obstruction, dysuria, lymphedema, vaginal discharge 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: EORTC questionnaire C15-PAL(12 months)
研究者
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna