A Comparative Analysis of Dysphagia Relief with External Beam Radiotherapy versus Brachytherapy with External Beam Conditioning in Advanced Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To compare dysphagia relief (change in grade of dysphagia) in radiation naïve esophageal cancer patients with high-grade dysphagia treated with external beam radiotherapy (30Gy in 10#) versus brachytherapy with external beam conditioning (EBRT 12Gy in 3# followed by weekly brachytherapy of 6 Gy weekly over 2 weeks)
研究概览
简要总结
A COMPARATIVE ANALYSIS OF DYSPHAGIA RELIEF WITH EXTERNAL BEAM RADIOTHERAPY VERSUS BRACHYTHERAPY WITH EXTERNAL BEAM CONDITIONING IN ADVANCED ESOPHAGEAL CANCER
We aim to study difficulty in swallowing in advanced esophageal cancer patients between two arms of treatment modality, in which one treatment arm is treated with radiation therapy from outside (EBRT) alone, and the other arm is treated with radiation therapy from outside (EBRT) for few fractions to relieve dysphagia followed by inside (Brachytherapy).
This study will be conducted at Homi Bhabha Cancer Hospital and Mahamana Pandit Madan Mohan Malaviya Cancer Centre, Varanasi. We will assess patients in terms of the score of dysphagia relief and duration of dysphagia relief in both arms via telephonic follow-up after radiation treatment and the assessment will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 19.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Endoscopic and biopsy-proven carcinoma of the esophagus either adenocarcinoma or squamous cell carcinoma Patient not suitable for radical treatment either Due to poor KPS Extent of local disease (Primary Stage T4b) Unsuitable for concurrent chemotherapy Metastatic disease at presentation Lesions of the thoracic esophagus and the abdominal esophagus that do not involve the cardiac of the stomach Recent imaging (a computed tomography (CT) of the chest and abdomen or whole body PETCT) not more than 3 months old Maximum tumor length not more than 10 cm Dysphagia immediately before radiation Karnofskys performance score is between 40 and 90 inclusive and at baseline Signed informed consent.
排除标准
- •Age less than 18 Expected intraluminal catheter insertion not possible even after conditioning radiotherapy Tracheoesophageal fistula or deep mucosal ulceration Perforation or massive esophageal bleeding Stents in situ (i.e. not removed before the first HDR ILBT) Previous thoracic radiation therapy for any cause either EBRT or ILBT Evidence of other uncontrolled malignancies or evidence of synchronous head and neck or lung primary cancers (regardless of whether those malignancies could be managed with curative intent) Pregnant or lactating patients.
结局指标
主要结局
To compare dysphagia relief (change in grade of dysphagia) in radiation naïve esophageal cancer patients with high-grade dysphagia treated with external beam radiotherapy (30Gy in 10#) versus brachytherapy with external beam conditioning (EBRT 12Gy in 3# followed by weekly brachytherapy of 6 Gy weekly over 2 weeks)
时间窗: To compare dysphagia relief (change in grade of dysphagia) in radiation naïve esophageal cancer patients with high-grade dysphagia treated with external beam radiotherapy (30Gy in 10#) versus brachytherapy with external beam conditioning (EBRT 12Gy in 3# followed by weekly brachytherapy of 6 Gy weekly over 2 weeks)
次要结局
- To compare the duration of dysphagia relief, dysphagia-free survival, and overall survival(18 months)