Improving post radiation dysphagia by limiting dose to dysphagia aspiration related structure (DARS)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To determine whether reducing the dose to dysphagia aspiration related structures with dysphagia optimized intensity modulated radiotherapy (do-IMRT) will improve in long term swallowing function without compromising any tumor control or disease specific survival.
研究概览
简要总结
This study would be prospective randomised controlled trial for patients undergoing primary chemo-radiotherapy for T1-4, N0-3, M0 Oro-larynopharyngeal cancers. Complete enumeration will be used. Therefore, all the patients coming to the R.R Centre cancer; SRMS IMS hospital,Bareilly, Uttar Pradesh which are falling in inclusion & exclusion criteria will be considered the sample.All patients will be randomised (1:1 ratio) to either standard Intensity Modulated Radiotherapy or dysphagia optimised Intensity Modulated Radiotherapy. Radiotherapy doses will be same in both groups i.e., 70 Gy in 35 fractions over 7 weeks However, patients allocated to do-IMRT group, dose constraints will be given to DARS, and no dose constraints will be given in standard Intensity Modulated Radiotherapy group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Histologically proven non-metastatic oro-larynopharyngeal carcinoma, Karnofsky performance score more than 70 , normal haemogram, renal function tests, liver function tests and those who can follow and understand study related advice and are willing to give consent.
排除标准
- •patient with prior or synchronous malignancy, prior treated with radiotherapy, metastatic oro-larynopharngeal carcinoma, patient underwent surgery.
结局指标
主要结局
To determine whether reducing the dose to dysphagia aspiration related structures with dysphagia optimized intensity modulated radiotherapy (do-IMRT) will improve in long term swallowing function without compromising any tumor control or disease specific survival.
时间窗: 3 years
次要结局
- asses quality of life and factors associated with dysphagia(3 years)
研究者
Prachi Upadhyay
SRMS IMS Hospital