DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- laryncegtomy free survival
研究概览
简要总结
To evaluate whether Transoral Laser Microsurgery (TLM) is non-inferior compared to Accelerated Radiotherapy (accRT) in the treatment of T1aN0M0 glottic SCC
详细描述
Since 2003 the Danish national standard treatment for T1aN0M0 glottic SCC has been accelerated RT (66Gy. 2 GY/fraction, 6 fractions/week). In 2012 cordectomy type I-III using TLM was introduced as an experimental treatment.
The DAHANCA 27 trial is a comparative non-inferiority phase II study comparing two timely separated national patient cohorts. Patients treated with radical TLM from September 2012 to April 2016 were included in the TLM cohort, and patients treated with accelerated RT from January 2003 to august 2012 were included in the RT cohort
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Danish patients aged ≥18 years diagnosed with a T1aN0M0 glottic squamous cell carcinoma (SCC)
排除标准
- •Unable to complete curative intended protocol treatment and/or planned follow up
- •informed concent
结局指标
主要结局
laryncegtomy free survival
时间窗: 5 years
Alive with larynx
次要结局
- any other treatment related morbidity(5 years)
- Local control(5 years)
- Ultimate tumor control(5 years)
- Overall survival(5 years)
- Voice quality(3 years)
- Radiation free survival(5 years)
研究者
Jens Overgaard
Professor, MD
Danish Head and Neck Cancer Group