跳至主要内容
临床试验/NCT00188318
NCT00188318已完成2 期

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

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 1998年6月最近更新:
适应症
干预措施

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

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

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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