Optimal Management of Malignant Dysphagia

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

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.

Study Overview

• Status: Terminated
• Conditions: Esophageal Cancer; Malignant Dysphagia
• Intervention / Treatment: Procedure: Stent insertion; Radiation: Brachytherapy

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G1A4
      • McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Self-expanding stent alone; All patients in Arm A will receive self-expanding stent alone	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.
Experimental: Brachytherapy and Stent therapy	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Monisha Sudarshan, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre; Principal Investigator: Lorenzo Ferri, MD, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre; Principal Investigator: Marc David, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre; Principal Investigator: David Roberge, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre; Principal Investigator: Serge Mayrand, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre; Principal Investigator: Kevin Waschke, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre; Principal Investigator: Eleanor Eckert, Nutritionist, McGill University Health Centre/Research Institute of the McGill University Health Centre; Principal Investigator: Myriam Martel, RN, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 2, 2011
• First Submitted That Met QC Criteria: June 3, 2011
• First Posted (Estimated): June 6, 2011

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Cancer; Dysphagia; Esophageal Cancer; Esophagus
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders; Esophageal Neoplasms
• Other Study ID Numbers: MalignantDysphagia