Comparison Study of Brachytherapy and Endoscopic Stenting for Dysphagia in Esophago-Gastric Junction Cancer
BRASTEGAC
The Comparison of Value of Brachytherapy and Endoscopic Stenting With SEMS in Palliative Treatment of Dysphagia Resulting From Adenocarcinoma of the Esophago-Gastric Junction
2 other identifiers
interventional
80
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2013
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 5, 2013
CompletedFirst Posted
Study publicly available on registry
February 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedFebruary 7, 2013
February 1, 2013
3 years
February 5, 2013
February 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The highest improvement of dysphagia grade
1 year
Time to the best swallowing improvement
1 year
Time to recurrent worsening of swallowing
1 year
The highest improvement of stricture diameter
1 year
Secondary Outcomes (5)
the procedure related morbidity
1 year
the procedure related mortality
1 year
The frequency of dysphagia related additional endoscopic interventions
1 year
Overall survival
1 year
Quality of life
1 year
Other Outcomes (1)
Cost analysis
1 year
Study Arms (2)
Brachytherapy
EXPERIMENTALSingle 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
OTHEREndoscopic 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
Interventions
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 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Lublinlead
- St Johns' Oncology Center in Lublincollaborator
Study Sites (2)
Second Department of General & Gastrointestinal Surgery & Oncological Surgery of the Alimantary Tract, Medical University of Lublin
Lublin, Lublin Voivodeship, 20-081, Poland
St. John's Cancer Center
Lublin, Lublin Voivodeship, 20-090, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
February 5, 2013
First Posted
February 7, 2013
Study Start
February 1, 2013
Primary Completion
February 1, 2016
Study Completion
December 1, 2017
Last Updated
February 7, 2013
Record last verified: 2013-02