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

NCT01786278 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2013-02-07

No results posted yet for this study

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.

Conditions

  • Adenocarcinoma of the Esophago-gastric Junction

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

Sponsors & Collaborators

  • St Johns' Oncology Center in Lublin

    collaborator UNKNOWN

  • Medical University of Lublin

    lead OTHER

Principal Investigators

  • Tomasz Skoczylas, MD, PhD · Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

  • Krzysztof Zinkiewicz, MD, PhD · Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

  • Grzegorz Wallner, Professor · Second Department of General & Gastrointestinal Surgery & Surgical Oncology of the Alimentary Tract, Medical University of Lublin

  • Elżbieta Starosławska, MD, PhD · St Johns' Oncology Center in Lublin

  • Dariusz Kieszko, MD, PhD · St Johns' Oncology Center in Lublin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2016-02-29
Completion
2017-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01786278 on ClinicalTrials.gov