NCT00120211已完成3 期
Phase III Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 855
- 主要终点
- Three Years Loco-regional Control
研究概览
简要总结
This trial compares the use of 6 fractions versus the standard 5 fractions of radiotherapy used in the treatment of head and neck cancer.
详细描述
The purpose of this trial is to study the clinical effects of increasing the weekly fraction number for locally advanced head and neck cancers by a multi-institutional prospective randomised trial. The primary endpoint is to clarify whether a six fraction per week protocol has a greater effect on the survival, as compared to the conventional five fraction per week protocol.
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
- •Head and Neck Cancer
排除标准
- •Unable to give an informed consent
研究组 & 干预措施
Radiotherapy: 6 Fractions
Experimental
干预措施: Accelerated Radiotherapy Fractionation (Radiation)
Radiotherapy: 5 fractions
Active Comparator
干预措施: Accelerated Radiotherapy Fractionation (Radiation)
结局指标
主要结局
Three Years Loco-regional Control
时间窗: 3 years
次要结局
- Disease-specific Survival(8 years)
- Overall Survival(8 years)
- Acute Adverse Effects
- Late Adverse Effects(8 years)
研究者
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