PatientsVille.com LogoPatientsVille.com

Adenocarcinoma of the Esophago-gastric Junction | Comparison Study of Brachytherapy and Endoscopic Stenting for Dysphagia in Esophago-Gastric Junction Cancer

Adenocarcinoma of the Esophago-gastric Junction research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Adenocarcinoma of the Esophago-gastric Junction

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Radiation:BrachytherapySingle 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 stentingEndoscopic 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 Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

BrachytherapySingle 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 StentingEndoscopic 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 Status

Unknown status

Start Date: February 2013

Completed Date: December 2017

Phase: Phase 2/Phase 3

Type: Interventional

Design:

Primary Outcome: The highest improvement of dysphagia grade

Secondary Outcome: the procedure related morbidity

Study sponsors, principal investigator, and references

Principal Investigator: Tomasz Skoczylas, MD, PhD

Lead Sponsor: Medical University of Lublin

Collaborator: St Johns' Oncology Center in Lublin

More information:https://clinicaltrials.gov/show/NCT01786278

Discuss Dysphagia