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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2016

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.

Interventions

  • 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.
  • 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

Arms, Groups and Cohorts

  • 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.
  • Other: 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

Clinical Trial Outcome Measures

Primary Measures

  • The highest improvement of dysphagia grade
    • Time Frame: 1 year
  • Time to the best swallowing improvement
    • Time Frame: 1 year
  • Time to recurrent worsening of swallowing
    • Time Frame: 1 year
  • The highest improvement of stricture diameter
    • Time Frame: 1 year

Secondary Measures

  • the procedure related morbidity
    • Time Frame: 1 year
  • the procedure related mortality
    • Time Frame: 1 year
  • The frequency of dysphagia related additional endoscopic interventions
    • Time Frame: 1 year
  • Overall survival
    • Time Frame: 1 year
  • Quality of life
    • Time Frame: 1 year

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medical University of Lublin
  • Collaborator
    • St Johns’ Oncology Center in Lublin
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tomasz Skoczylas, MD, PhD – Medical University of Lublin
  • Overall Official(s)
    • Tomasz Skoczylas, MD, PhD, Principal Investigator, Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
    • Krzysztof Zinkiewicz, MD, PhD, Principal Investigator, Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
    • Grzegorz Wallner, Professor, Principal Investigator, Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin
    • Elżbieta Starosławska, MD, PhD, Principal Investigator, St Johns’ Oncology Center in Lublin
    • Dariusz Kieszko, MD, PhD, Principal Investigator, St Johns’ Oncology Center in Lublin
  • Overall Contact(s)
    • Tomasz Skoczylas, MD, PhD, +48 81 5328810, tomskocz@yahoo.com

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