Optimal Management of Malignant Dysphagia
|ClinicalTrials.gov Identifier: NCT01366833|
Recruitment Status : Unknown
Verified June 2011 by McGill University Health Center.
Recruitment status was: Not yet recruiting
First Posted : June 6, 2011
Last Update Posted : June 6, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Dysphagia Esophageal Cancer||Radiation: Brachytherapy Procedure: Stent insertion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Management of Malignant Dysphagia: Stent vs. Stent Plus Endoluminal Brachytherapy for the Palliation of Dysphagia in Metastatic Esophageal Cancer|
|Study Start Date :||June 2011|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2013|
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||
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.
- To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366833
|Contact: Myriam Martel, RNemail@example.com|
|McGill University Health Centre||Not yet recruiting|
|Montreal, Quebec, Canada, H3G1A4|
|Principal Investigator:||Lorenzo Ferri, MD, PhD||McGill University Health Center|
|Principal Investigator:||Monisha Sudarshan, MD||McGill University Health Center|
|Principal Investigator:||Marc David, MD||McGill University Health Center|
|Principal Investigator:||David Roberge, MD||McGill University Health Center|
|Principal Investigator:||Serge Mayrand, MD||McGill University Health Center|
|Principal Investigator:||Kevin Waschke, MD||McGill University Health Center|
|Principal Investigator:||Eleanor Eckert, Nutritionist||McGill University Health Center|
|Principal Investigator:||Myriam Martel, RN||McGill University Health Center|