Short Course Accelerated Radiation Therapy in Palliative Treatment of Advanced Head and Neck Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with symptomatic advanced head and neck cancer.
详细描述
The study wants to define the maximum tolerated dose (MTD) of a conformal short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of metastatic or locally advanced head and neck 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 locally advanced or metastatic H&N 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) performance status < 3
排除标准
- •prior RT to the same region.
结局指标
主要结局
Maximum tolerated dose
时间窗: 1 year
The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients
次要结局
- Quality of life(1 year)
- Late toxicity(1 year)
- Pain relief(1 year)
- Acute toxicity(1 year)
研究者
Alessio Giuseppe Morganti
Professor
IRCCS Azienda Ospedaliero-Universitaria di Bologna