Optimal Management of Malignant Dysphagia
Malignant Dysphagia - Esophageal Cancer
Conditions: official terms
Deglutition Disorders - Esophageal Neoplasms
Conditions: Keywords
Dysphagia, Esophagus, Cancer, Esophageal Cancer
Study Type
Study Phase
Phase 1
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Name: Brachytherapy Type: Radiation
Name: Stent insertion Type: Procedure
Overall Status
Not yet recruiting
According to the Canadian Cancer Society there are approximately 1700 new cases of esophageal cancer per year in Canada. As most of these patients are diagnosed in advanced stages of the disease, 1800 deaths are estimated from this cancer annually . Progressive dysphagia is the most common presenting symptom and impacts not only the patient's quality of life but the ability to tolerate life prolonging treatments such as systemic chemotherapy.

Although there are several therapeutic modalities to alleviate malignant dysphagia including laser, photodynamic therapy and cryotherapy , the use of stents and radiotherapy are the most commonly employed. However, the optimal approach to effective, timely treatment of malignant dysphagia remains a challenge. The investigators conducted a preliminary retrospective review to investigate such palliation procedures and found that a multi-modality approach may yield the most favourable results .

Therefore, our clinical trial will examine the effectiveness of adding a single dose of brachytherapy to patients with severe dysphagia who have already been treated with a endoscopically placed self-expanding metallic stent.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age ≥18 years

- Confirmed esophageal/gastroesophageal (GEJ) cancer (Siewert Type I and Type II only) of any histology on biopsy

- Dysphagia score ≥2

- Stage IV cancer/Metastatic disease

Exclusion Criteria:

- Expected life expectancy < 3 months

- Inability to undergo stent insertion

- Siewert Type III gastroesophageal cancer

- Esophageal-Airway fistula
McGill University Health Centre
Montreal, Quebec, Canada
Status: Not yet recruiting
Start Date
June 2011
Completion Date
December 2013
McGill University Health Center
McGill University Health Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page