We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01786278
Recruitment Status : Unknown
Verified February 2013 by Tomasz Skoczylas, Medical University of Lublin.
Recruitment status was:  Recruiting
First Posted : February 7, 2013
Last Update Posted : February 7, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Esophago-gastric Junction Radiation: Brachytherapy Procedure: Endoscopic stenting Phase 2 Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2013
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.
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


Outcome Measures

Primary Outcome Measures :
  1. The highest improvement of dysphagia grade [ Time Frame: 1 year ]
  2. Time to the best swallowing improvement [ Time Frame: 1 year ]
  3. Time to recurrent worsening of swallowing [ Time Frame: 1 year ]
  4. The highest improvement of stricture diameter [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. the procedure related morbidity [ Time Frame: 1 year ]
  2. the procedure related mortality [ Time Frame: 1 year ]
  3. The frequency of dysphagia related additional endoscopic interventions [ Time Frame: 1 year ]
  4. Overall survival [ Time Frame: 1 year ]
  5. Quality of life [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Cost analysis [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786278


Contacts
Contact: Tomasz Skoczylas, MD, PhD +48 81 5328810 tomskocz@yahoo.com

Locations
Poland
Second Department of General & Gastrointestinal Surgery & Oncological Surgery of the Alimantary Tract, Medical University of Lublin Recruiting
Lublin, Lubelskie, Poland, 20-081
Contact: Tomasz Skoczylas, MD, PhD    +48 81 5328810    tomskocz@yahoo.com   
Principal Investigator: Tomasz Skoczylas, MD, PhD         
Principal Investigator: Krzysztof Zinkiewicz, MD, PhD         
Sub-Investigator: Witold Zgodziński, MD, PhD         
Sub-Investigator: Marek Majewski, MD, PhD         
Sub-Investigator: Grzegorz Wallner, Professor         
Sub-Investigator: Andrzej Dąbrowski, Professor         
Sub-Investigator: Witold Krupski, Professor         
St. John's Cancer Center Recruiting
Lublin, Lubelskie, Poland, 20-090
Contact: Dariusz Kieszko, MD, PhD    +48 81 7477511 ext 142      
Principal Investigator: Elżbieta Starosławska, MD, PhD         
Principal Investigator: Dariusz Kieszko, MD, PhD         
Sub-Investigator: Paweł Cisek, MD         
Sub-Investigator: Krzysztof Paprota, MD, PhD         
Sub-Investigator: Tomasz Kubiatowski, MD, PhD         
Sub-Investigator: Bożena Kukiełka-Budny, MD, PhD         
Sponsors and Collaborators
Medical University of Lublin
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: Krzysztof Zinkiewicz, 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: Dariusz Kieszko, MD, PhD St Johns' Oncology Center in Lublin
More Information

Responsible Party: Tomasz Skoczylas, MD, PhD, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT01786278     History of Changes
Other Study ID Numbers: EGC-DYS-0254/281/2011-MUL
MULEK-0254/281/2011 ( Other Identifier: Medical University of Lublin )
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: February 7, 2013
Last Verified: February 2013

Keywords provided by Tomasz Skoczylas, Medical University of Lublin:
adenocarcinoma
esophago-gastric junction
dysphagia
brachytherapy
endoscopic stenting

Additional relevant MeSH terms:
Adenocarcinoma
Deglutition Disorders
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms