Clinical trial NCT01786278: Comparison Study of Brachytherapy and Endoscopic Stenting for Dysphagia in Esophago-Gastric Junction Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Adenocarcinoma of the Esophago-gastric Junction
Keywords: adenocarcinoma
esophago-gastric junction
dysphagia
brachytherapy
endoscopic stenting
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
Collaborators: name: St Johns' Oncology Center in Lublin
First posted: 2013-02-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: The highest improvement of dysphagia grade
timeFrame: 1 year
measure: Time to the best swallowing improvement
timeFrame: 1 year
measure: Time to recurrent worsening of swallowing
timeFrame: 1 year
measure: The highest improvement of stricture diameter
timeFrame: 1 year
Secondary outcomes:
measure: the procedure related morbidity
timeFrame: 1 year
measure: the procedure related mortality
timeFrame: 1 year
measure: The frequency of dysphagia related additional endoscopic interventions
timeFrame: 1 year
measure: Overall survival
timeFrame: 1 year
measure: Quality of life
timeFrame: 1 year
Other outcomes:
measure: Cost analysis
timeFrame: 1 year
Locations:
city: Lublin
country: Poland
facility: Second Department of General & Gastrointestinal Surgery & Oncological Surgery of the Alimantary Tract, Medical University of Lublin
state: Lubelskie
city: Lublin
country: Poland
facility: St. John's Cancer Center
state: Lubelskie
Study officials:
affiliation: Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
name: Tomasz Skoczylas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
name: Krzysztof Zinkiewicz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
name: Grzegorz Wallner, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: St Johns' Oncology Center in Lublin
name: Elżbieta Starosławska, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Johns' Oncology Center in Lublin
name: Dariusz Kieszko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: