Optimal Management of Malignant Dysphagia

Study Overview
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Brief Summary
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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.

Official Title
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Management of Malignant Dysphagia: Stent vs. Stent Plus Endoluminal Brachytherapy for the Palliation of Dysphagia in Metastatic Esophageal Cancer

Conditions
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Malignant Dysphagia, Esophageal Cancer

Intervention / Treatment
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* Radiation: Brachytherapy
* Procedure: Stent insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-expanding stent alone<br>All patients in Arm A will receive self-expanding stent alone | Procedure: Stent insertion<br>* 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.<br>|
| Experimental: Brachytherapy and Stent therapy<br> | Radiation: Brachytherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, Esophagus, Cancer, Esophageal Cancer