The Comparison of Value of Brachytherapy and Endoscopic Stenting With SEMS in Palliative Treatment of Dysphagia Resulting From Adenocarcinoma of the Esophago-Gastric Junction
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The highest improvement of dysphagia grade
研究概览
简要总结
The objective of the study is comparison of the efficacy and safety of palliative therapy with single-dose brachytherapy or selfexpanding metal stents (SEMS) in malignant dysphagia resulting from adenocarcinoma of the esophago-gastric junction.
详细描述
Over the past two decades it has been observed a clear trend in the increasing incidence of adenocarcinoma of the esophagus and esophago-gastric junction. More than half of these patients already have inoperable disease at presentation. Most of them need palliative treatment to relieve progressive dysphagia. Presently, endoscopic placement of a covered selfexpanding metal stent is the most commonly used method for treatment of malignant dysphagia. Cancer overgrowth and stent migration are the most common complications of endoscopic stenting and they occur more frequently with longer time from stenting. Specific location at esophago-gastric junction at the end point of the propulsive force after swallow may predispose stents for easier migration to the stomach. Additionally, the advances in chemotherapy have resulted in improved median survival of advanced adenocarcinoma ot the stomach and esophago-gastric junction even up to 10-12 months increasing a potential for higher chance for occurrence of stent complications. Brachytherapy has been proved to be a valuable and durable method to treat malignant dysphagia resulting from esophageal and mainly squamous cell cancer. For many years irradiation was not recommended for adenocarcinoma of the esophagus and esophago-gastric junction due to their putative low sensitivity to radiotherapy. Recently external beam radiation has been incorporated to a combined modality therapy regimens also for adenocarcinoma of the esophagus. Thus, brachytherapy could be an attractive and durable method for improving swallowing in adenocarcinoma of the esophago-gastric junction, as well. Single-dose brachytherapy and endoscopic stenting with SEMS in relieving dysphagia resulting from clearly defined adenocarcinoma of the esophago-gastric junction have not been compared yet.
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
- 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
- •Adenocarcinoma of the esophago-gastric junction defined as adenocarcinoma involving lower esophagus and upper stomach with epicenter of the primary tumor between 5cm above and 5cm below the anatomic esophago-gastric junction
- •Inoperable cancer - locally advanced irresectible cancer, distant metastasis or patient's condition does not fit to undergo a curative therapy
- •Dysphagia score 2-4
- •Performance status 60-100
- •Signed informed consent
排除标准
- •Esophageal squamous cell carcinoma
- •Esophageal adenocarcinoma
- •Gastric cancer
- •Performance status <60
- •Instable cardiocirculatory or respiratory disorder
- •Concurrent external beam radiation therapy
- •Previous anticancer therapy related to current adenocarcinoma of the esophago-gastric junction
研究组 & 干预措施
Brachytherapy
Single dose of 12 Gy generated using a flexible applicator containing Iridium 192 with the range of irradiation of 1cm from the applicator axis. The extent of irradiation will cover the whole length of cancer stricture and 2cm beyond proximal and distal end of the tumor.
干预措施: Brachytherapy (Radiation)
Endoscopic Stenting
Endoscopic stenting with partially covered selfexpandable metalic stents positioned across the cancer stricture and extending 2cm proximally and 2cm distally to the proximal and distal end of the tumor, respectively
干预措施: Endoscopic stenting (Procedure)
结局指标
主要结局
The highest improvement of dysphagia grade
时间窗: 1 year
Time to the best swallowing improvement
时间窗: 1 year
Time to recurrent worsening of swallowing
时间窗: 1 year
The highest improvement of stricture diameter
时间窗: 1 year
次要结局
- the procedure related morbidity(1 year)
- the procedure related mortality(1 year)
- The frequency of dysphagia related additional endoscopic interventions(1 year)
- Overall survival(1 year)
- Quality of life(1 year)
研究者
Tomasz Skoczylas
MD, PhD
Medical University of Lublin
