SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Head and Neck Cancer: an Interventional, Randomized, 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 symptomatic head and neck (H&N) malignant lesions
详细描述
Standard treatment for H&N lesions (3000 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 H&N 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 fraction
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 initial symptoms (pain, bleeding, dysphagia, hoarseness, stridor, dehydration, malnutrition) after radiotherapy, evaluated as none-mild-moderate-severe before and after treatment
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