A Phase II Study of Hyperfractionated Accelerated Radiotherapy Delivered With Integrated Neck Surgery for Node-positive Cases in Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Toxicities as per CTCAE
研究概览
简要总结
This study is examining the effects of increasing the dose of radiation given to treat head and neck cancer. Radiation doses to the primary cancer are higher than usually given; lymph glands of the neck will also be treated at a lower dose. Surgery on the lymph glands my be necessary in the future. Radiation treatments given in small fractions twice a day allows a higher dose to be delivered than if the treatment was given once a day. This study will enroll patients at three sequential increasing dose levels. Approximately 40 patients will be enrolled at each dose level.
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 squamous cell carcinoma
- •Larynx & pharynx (except Nasopharyngeal carcinoma)
- •Stage III & IV, but any stage hypopharynx
- •Informed Consent
排除标准
- 未提供
研究组 & 干预措施
Hyperfractionated Accelerated Radiotherapy
Hypofractionated Accelerated Radiotherapy with integrated neck surgery
干预措施: hyperfractionated accelerated radiotherapy (Procedure)
结局指标
主要结局
Toxicities as per CTCAE
时间窗: 1 yr
次要结局
未报告次要终点
