Not provided
Not provided
Not provided
Not provided
Not provided
Low accrual
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-expanding stent alone | Active Comparator | All patients in Arm A will receive self-expanding stent alone |
|
| Brachytherapy and Stent therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brachytherapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks | 2 years |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Ferri, MD, PhD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Monisha Sudarshan, MD | 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Montreal | Quebec | H3G1A4 | Canada |
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D003680 | Deglutition Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Stent insertion | Procedure | 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. |
|
| Principal Investigator |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |