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

February 5, 2013 updated by: Tomasz Skoczylas, Medical University of Lublin

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-090
        • Recruiting
        • St. John's Cancer Center
        • Principal Investigator:
          • Elżbieta Starosławska, MD, PhD
        • Sub-Investigator:
          • Bożena Kukiełka-Budny, MD, PhD
        • Contact:
          • Dariusz Kieszko, MD, PhD
          • Phone Number: 142 +48 81 7477511
        • Principal Investigator:
          • Dariusz Kieszko, MD, PhD
        • Sub-Investigator:
          • Paweł Cisek, MD
        • Sub-Investigator:
          • Krzysztof Paprota, MD, PhD
        • Sub-Investigator:
          • Tomasz Kubiatowski, MD, PhD
      • Lublin, Lubelskie, Poland, 20-081
        • Recruiting
        • Second Department of General & Gastrointestinal Surgery & Oncological Surgery of the Alimantary Tract, Medical University of Lublin
        • Contact:
        • Sub-Investigator:
          • Witold Zgodziński, MD, PhD
        • Sub-Investigator:
          • Marek Majewski, MD, PhD
        • Sub-Investigator:
          • Witold Krupski, Professor
        • Principal Investigator:
          • Tomasz Skoczylas, MD, PhD
        • Principal Investigator:
          • Krzysztof Zinkiewicz, MD, PhD
        • Sub-Investigator:
          • Grzegorz Wallner, Professor
        • Sub-Investigator:
          • Andrzej Dąbrowski, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The highest improvement of dysphagia grade
Time Frame: 1 year
1 year
Time to the best swallowing improvement
Time Frame: 1 year
1 year
Time to recurrent worsening of swallowing
Time Frame: 1 year
1 year
The highest improvement of stricture diameter
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 1 year
1 year
Quality of life
Time Frame: 1 year
1 year
the procedure related morbidity
Time Frame: 1 year
1 year
the procedure related mortality
Time Frame: 1 year
1 year
The frequency of dysphagia related additional endoscopic interventions
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Cost analysis
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lublin

Collaborators

St Johns' Oncology Center in Lublin

Investigators

  • Principal Investigator: Tomasz Skoczylas, MD, PhD, Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
  • Principal Investigator: Grzegorz Wallner, Professor, Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
  • Principal Investigator: Elżbieta Starosławska, MD, PhD, St Johns' Oncology Center in Lublin
  • Principal Investigator: Krzysztof Zinkiewicz, MD, PhD, Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
  • Principal Investigator: Dariusz Kieszko, MD, PhD, St Johns' Oncology Center in Lublin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 7, 2013

Study Record Updates

Last Update Posted (Estimate)

February 7, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGC-DYS-0254/281/2011-MUL
  • MULEK-0254/281/2011 (Other Identifier: Medical University of Lublin)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adenocarcinoma of the Esophago-gastric Junction

Clinical Trials on Brachytherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe