Optimal Management of Malignant Dysphagia

Summary

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.

Conditions

• Malignant Dysphagia
• Esophageal Cancer

Interventions

RADIATION

Brachytherapy

Patients in arm B will receive a single dose of brachytherapy (10Gy) via a 10 or 13 mm catheter within 10days of stent insertion. Patients on the study will not be given preferential treatment, and will not be prioritized over patients treated with brachytherapy not on the study.

PROCEDURE

Stent insertion

After placement of clips to mark the proximal and distal extent of the tumor, an endoscopically placed self-expanding metallic stent (WallFlex™ Partially Covered Esophageal Stent by Boston Scientific) will be inserted within 10 days of recruitment. This will be the only intervention in Arm A patients.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Lorenzo Ferri, MD, PhD · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Monisha Sudarshan, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Marc David, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

• David Roberge, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Serge Mayrand, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Kevin Waschke, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Eleanor Eckert, Nutritionist · McGill University Health Centre/Research Institute of the McGill University Health Centre

• Myriam Martel, RN · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-06-30

Primary Completion

2017-03-31

Completion

2017-03-31

Countries

• Canada

Study Locations