Comparison Study of Brachytherapy and Endoscopic Stenting for Dysphagia in Esophago-Gastric Junction Cancer
Conditions
Adenocarcinoma of the Esophago-gastric Junction
Conditions: official terms
Adenocarcinoma - Esophageal Neoplasms
Conditions: Keywords
adenocarcinoma, esophago-gastric junction, dysphagia, brachytherapy, endoscopic stenting
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Brachytherapy Type: Radiation
Name: Endoscopic stenting Type: Procedure
Overall Status
Recruiting
Summary
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.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
Locations
Second Department of General & Gastrointestinal Surgery & Oncological Surgery of the Alimantary Tract, Medical University of Lublin
Lublin, Lubelskie, Poland
Status: Recruiting
Contact: Tomasz Skoczylas, MD, PhD - +48 81 5328810 - tomskocz@yahoo.com
St. John's Cancer Center
Lublin, Lubelskie, Poland
Status: Recruiting
Contact: Dariusz Kieszko, MD, PhD - +48 81 7477511
Start Date
February 2013
Completion Date
December 2017
Sponsors
Medical University of Lublin
Source
Medical University of Lublin
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page