NCT01548846终止2 期
Impact of Tomotherapy on Xerostomia and Quality of Life of Patients With Cancer of the Upper Aero-digestive Tract
Centre Francois Baclesse2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- the proportion of patients with xerostomia
研究概览
简要总结
This is a study whose main objective is to evaluate prospectively the proportion of patients with severe xerostomia one year after treatment with tomotherapy for head and neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient (e) old (e) over 18 years
- •Patients with squamous cell carcinoma of head and neck (oral cavity, oropharynx, lymphadenopathy without gateway) histologically proven.
- •Patient targeted for head and neck radiotherapy by Tomotherapy exclusive with or without concurrent chemotherapy (containing platinum)
- •Indication of head and neck radiotherapy bilateral
- •All of the TNM stage except metastatic
- •Patient has signed informed consent for participation in the study
- •Mastery of the French language
排除标准
- •History of head and neck radiotherapy
- •Indication of head and neck radiotherapy unilateral
- •Personal history of malignant tumors uncontrolled over the past 5 years
- •History of oral sicca syndrome
- •Surgical removal of one or more salivary glands (parotid, submandibular gland, sublingual gland)
- •Concomitant treatment with amifostine
- •Concomitant treatment with cetuximab
- •Primary tumor of the salivary glands
- •Head and neck hyperfractionated radiotherapy and / or accelerated
- •Head and neck radiotherapy hypofractionated
- •Metastatic disease
- •Patient deprived of liberty, under guardianship
- •Any medical condition or psychological associate that could compromise the patient's ability to participate in the study
- •Refusal of the patient.
结局指标
主要结局
the proportion of patients with xerostomia
时间窗: 12 months after completion of radiotherapy.
Estimate the proportion of patients with xerostomia of grade greater than or equal to 2 assessed by the scale of late toxicity RTOG / EORTC 12 months after completion of radiotherapy.
次要结局
- Evaluation of acute and late xerostomia(after 3, 6 and 12 months after radiotherapy)
- Evaluation of quality of life and fatigue(At 3, 6 and 12 months after radiotherapy)
- Evaluation of the incidence of acute side effects of radiotherapy(Weekly during radiotherapy)
- Evaluation of overall survival and progression-free survival(at 3, 6 and 12 months after radiotherapy)
- Measurement of salivary flow with and without stimulation(at 3, 6 and 12 months after end of radiotherapy)
- Evaluation of the incidence of late side effects of radiotherapy(At 3, 6 and 12 months after radiotherapy)
研究者
研究点 (2)
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