Swallowing Sparing IMRT (SW-IMRT) Versus Standard Parotid Sparing IMRT (ST-IMRT) in the Treatment of Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Objective assessment of the swallowing function (dysphagia) at regular intervals
研究概览
简要总结
To clinically validate whether SW-IMRT actually reduce the occurrence of swallowing dysfunction as compared to ST-IMRT.
详细描述
Patients are randomly assigned to either ST-IMRT or SW-IMRT.
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
- Single (Participant)
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
- •Patients with squamous cell carcinoma and requiring whole neck irradiation as a part of either definitive RT alone or in combination with chemotherapy or post-operative RT either alone or in combination with chemotherapy.
排除标准
- •Previous radiotherapy to the head and neck region or prior malignancies, and/or distant metastases.
结局指标
主要结局
Objective assessment of the swallowing function (dysphagia) at regular intervals
时间窗: 6 months
Objective assessment of swallowing will be made by videofluoroscopy and scored by Dynamic Imaging Grade of swallowing toxicity scale (DIGEST) and will be scored on a scale of 0 (no dysphagia) to 4 (life threatening )
Subjective assessment of the swallowing function (dysphagia) at regular intervals
时间窗: 6 months
Subjective assessment of swallowing function (dysphagia) will be scored on a scale of 0 (no dysphagia) to 4 (life threatening consequences; urgent intervention indicated) each follow-up visit on the basis of National Cancer Institute Common Terminology Criteria for Adverse Events, version 4 (CTCAE 4).
次要结局
- local control(6 months)