Comparison Study of Brachytherapy and Endoscopic Stenting for Dysphagia in Esophago-Gastric Junction Cancer

Adenocarcinoma of the Esophago-gastric Junction Clinical Trial

— BRASTEGAC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01786278
• Other study ID #: EGC-DYS-0254/281/2011-MUL
• Secondary ID: MULEK-0254/281/2
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: February 5, 2013
• Last updated: February 5, 2013
• Start date: February 2013
• Est. completion date: December 2017

Study information

• Verified date: February 2013
• Source: Medical University of Lublin
• Contact: Tomasz Skoczylas, MD, PhD
• Phone: +48 81 5328810
• Email: tomskocz[@]yahoo.com
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Esophago-gastric Junction
• Esophageal Neoplasms

Intervention

Radiation:
• 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.

Procedure:
• 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

Locations

Country	Name	City	State
Poland	Second Department of General & Gastrointestinal Surgery & Oncological Surgery of the Alimantary Tract, Medical University of Lublin	Lublin	Lubelskie
Poland	St. John's Cancer Center	Lublin	Lubelskie

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Lublin	St Johns' Oncology Center in Lublin

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost analysis		1 year	No
Primary	The highest improvement of dysphagia grade		1 year	No
Primary	Time to the best swallowing improvement		1 year	No
Primary	Time to recurrent worsening of swallowing		1 year	No
Primary	The highest improvement of stricture diameter		1 year	No
Secondary	the procedure related morbidity		1 year	Yes
Secondary	the procedure related mortality		1 year	Yes
Secondary	The frequency of dysphagia related additional endoscopic interventions		1 year	No
Secondary	Overall survival		1 year	No
Secondary	Quality of life		1 year	No