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Adenocarcinoma of the Esophago-gastric JunctionPhase 2/3BRASTEGACNCT01786278

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

A Phase 2/3 study testing Brachytherapy and Endoscopic stenting in people with Adenocarcinoma of the Esophago-gastric Junction, run by Medical University of Lublin at 2 sites in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Brachytherapy and Endoscopic stenting
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
2 sitesPoland
Study dates
Feb 2013to Dec 2017
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Tomasz Skoczylas, MD, PhD contact

+48 81 5328810

tomskocz@yahoo.com

Poland2 sites, 2 recruiting

  • Second Department of General & Gastrointestinal Surgery & Oncological Surgery of the Alimantary Tract, Medical University of Lublin

    Lublin, Lublin Voivodeship, 20-081

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

    Tomasz Skoczylas, MD, PhD

    Recruiting

  • St. John's Cancer Center

    Lublin, Lublin Voivodeship, 20-090

    Dariusz Kieszko, MD, PhD, +48 81 7477511 ext. 142

    Elżbieta Starosławska, MD, PhD

    Recruiting

Other trials in Poland

About this study

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

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.

Read the 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.

Being tested
Brachytherapy, Endoscopic stenting
Keywords
adenocarcinoma, esophago-gastric junction, dysphagia, brachytherapy, endoscopic stenting
Medical subject headings
Adenocarcinoma, Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrachytherapyRadiation

    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 stentingProcedure or surgery

    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

Study groups in NCT01786278
Study groupRoleWhat they receive
BrachytherapyExperimentalSingle 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.
Receives: Radiation: Brachytherapy
Endoscopic StentingOtherEndoscopic 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
Receives: Procedure: Endoscopic stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The highest improvement of dysphagia grade

    Measured: 1 year

  2. Time to the best swallowing improvement

    Measured: 1 year

  3. Time to recurrent worsening of swallowing

    Measured: 1 year

  4. The highest improvement of stricture diameter

    Measured: 1 year

Secondary outcomes (5)

  1. the procedure related morbidity

    Measured: 1 year

  2. the procedure related mortality

    Measured: 1 year

  3. The frequency of dysphagia related additional endoscopic interventions

    Measured: 1 year

  4. Overall survival

    Measured: 1 year

  5. Quality of life

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionFeb 2016 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01786278
Sponsor's protocol ID
EGC-DYS-0254/281/2011-MUL
Other IDs
MULEK-0254/281/2011
Acronym
BRASTEGAC
Status last verified
Feb 2013
First submitted
5 Feb 2013
Last updated
7 Feb 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Brachytherapy and Endoscopic stenting in people with Adenocarcinoma of the Esophago-gastric Junction, run by Medical University of Lublin at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tomasz Skoczylas, MD, PhD (+48 81 5328810, tomskocz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The highest improvement of dysphagia grade (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01786278.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2013.

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