Trial Title:
Comparison Study of Brachytherapy and Endoscopic Stenting for Dysphagia in Esophago-Gastric Junction Cancer
NCT ID:
NCT01786278
Condition:
Adenocarcinoma of the Esophago-gastric Junction
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Deglutition Disorders
Conditions: Keywords:
adenocarcinoma
esophago-gastric junction
dysphagia
brachytherapy
endoscopic stenting
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Brachytherapy
Description:
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.
Arm group label:
Brachytherapy
Intervention type:
Procedure
Intervention name:
Endoscopic stenting
Description:
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
Arm group label:
Endoscopic Stenting
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Department of General & Gastrointestinal Surgery & Oncological Surgery of the Alimantary Tract, Medical University of Lublin
Address:
City:
Lublin
Zip:
20-081
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Tomasz Skoczylas, MD, PhD
Phone:
+48 81 5328810
Email:
tomskocz@yahoo.com
Investigator:
Last name:
Tomasz Skoczylas, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Krzysztof Zinkiewicz, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Witold Zgodziński, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Marek Majewski, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Grzegorz Wallner, Professor
Email:
Sub-Investigator
Investigator:
Last name:
Andrzej Dąbrowski, Professor
Email:
Sub-Investigator
Investigator:
Last name:
Witold Krupski, Professor
Email:
Sub-Investigator
Facility:
Name:
St. John's Cancer Center
Address:
City:
Lublin
Zip:
20-090
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Dariusz Kieszko, MD, PhD
Phone:
+48 81 7477511
Phone ext:
142
Investigator:
Last name:
Elżbieta Starosławska, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Dariusz Kieszko, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Paweł Cisek, MD
Email:
Sub-Investigator
Investigator:
Last name:
Krzysztof Paprota, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Tomasz Kubiatowski, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Bożena Kukiełka-Budny, MD, PhD
Email:
Sub-Investigator
Start date:
February 2013
Completion date:
December 2017
Lead sponsor:
Agency:
Medical University of Lublin
Agency class:
Other
Collaborator:
Agency:
St Johns' Oncology Center in Lublin
Agency class:
Other
Source:
Medical University of Lublin
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01786278
