- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01366833
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Myriam Martel, RN
- Phone Number: 514-934-1934
- Email: myriam_martel@yahoo.ca
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3G1A4
- McGill University Health Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
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
|
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
|
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
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
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
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MalignantDysphagia
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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