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

NCT ID: NCT01786278

Last Updated: 2013-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-12-31

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.

Conditions

Adenocarcinoma of the Esophago-gastric Junction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Brachytherapy

Intervention Type: RADIATION

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

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

Group Type: OTHER

Endoscopic stenting

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: RADIATION

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St Johns' Oncology Center in Lublin

UNKNOWN

Sponsor Role: collaborator

Medical University of Lublin

OTHER

Sponsor Role: lead

Responsible Party

Tomasz Skoczylas

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomasz Skoczylas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

Krzysztof Zinkiewicz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

Grzegorz Wallner, Professor

Role: PRINCIPAL_INVESTIGATOR

Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

Elżbieta Starosławska, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St Johns' Oncology Center in Lublin

Dariusz Kieszko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

St Johns' Oncology Center in Lublin

Locations

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

Lublin, Lublin Voivodeship, Poland

Site Status: RECRUITING

St. John's Cancer Center

Lublin, Lublin Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Tomasz Skoczylas, MD, PhD

Role: CONTACT

tomskocz@yahoo.com

+48 81 5328810

Facility Contacts

Tomasz Skoczylas, MD, PhD

Role: primary

tomskocz@yahoo.com

+48 81 5328810

Dariusz Kieszko, MD, PhD

Role: primary

+48 81 7477511 ext. 142

Other Identifiers

MULEK-0254/281/2011

Identifier Type: OTHER

Identifier Source: secondary_id

EGC-DYS-0254/281/2011-MUL

Identifier Type: -

Identifier Source: org_study_id