NCT02024035已完成不适用
Health Economic Evaluation of Tomotherapy and Dynamic Arctherapy in ENT Epidermoid Carcinoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 14
- 主要终点
- The various of cost between tomotherapy and Intensity Modulation Radiation Therapy (IMRT)
研究概览
简要总结
The purpose of this study is to do health economic evaluation of tomotherapy and dynamic arctherapy (2 techniques exist: RapidArc and Vmat).
This study evaluate also local disease control after 18 months in patients with an ENT epidermoid carcinoma and treated by tomotherapy orarctherapy .
The number of patients required in this study is: 300:
- Number of patients treated with tomotherapy: 120
- Number of patients treated with dynamic arctherapy RapidArc: 120
- Number of patients treated with dynamic arctherapy Vmat: 60
This is a prospective; multicentric and non randomized study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age >= 18 years
- •Histologically proven carcinoma
- •Cavum Epidermoïd or undifferentiated carcinoma; or oropharynx epidermoïd carcinoma; or oral cavity epidermoïd carcinoma
- •Stade T1 to T4
- •Patient with no surgery ( except laser partial surgery and ganglionic cleaning out)
- •Bilateral ganlionic cervical area irradiation
- •Covered by a medical insurance.
排除标准
- •Prior history of other malignancies in the last 5 years(except non evolutive ENT cancer or squamous cell carcinoma )
- •Re-irradiation indication
- •Unilateral cervical area irradiation
- •Post-operative radiotherapy
- •Patient treated by amifostine
- •Impossible follow-up
结局指标
主要结局
The various of cost between tomotherapy and Intensity Modulation Radiation Therapy (IMRT)
时间窗: 18 months
The purpose of this study is to realise a Health economic evaluation of the various cost between tomotherapy and Intensity Modulation Radiation Therapy (IMRT)
次要结局
- To determine the rate of disease local control(Baseline, Month 6; Month 18)
- The economic impact of the learning curve of the tomotherapy process, the operating procedures and the activity of the centres(18 months)
- To determine the difference of cost for the preparation phase and the irradiation phase of the radiotherapy procedure(18 months)
- The salivary toxicity(at 6; 12 and 18 months post treatment)
研究者
研究点 (14)
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