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The Comparison of Value of Brachytherapy and Endoscopic Stenting With SEMS in Palliative Treatment of Dysphagia Resulting From Adenocarcinoma of the Esophago-Gastric Junction


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Esophago-gastric Junction

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Trial Information

The Comparison of Value of Brachytherapy and Endoscopic Stenting With SEMS in Palliative Treatment of Dysphagia Resulting From Adenocarcinoma of the Esophago-Gastric Junction


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The highest improvement of dysphagia grade

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Tomasz Skoczylas, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

Authority:

Poland: Ethics Committee

Study ID:

EGC-DYS-0254/281/2011-MUL

NCT ID:

NCT01786278

Start Date:

February 2013

Completion Date:

December 2017

Related Keywords:

  • Adenocarcinoma of the Esophago-gastric Junction
  • adenocarcinoma
  • esophago-gastric junction
  • dysphagia
  • brachytherapy
  • endoscopic stenting
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Deglutition Disorders

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