Trial Information
Management of Malignant Dysphagia: Stent vs. Stent Plus Endoluminal Brachytherapy for the Palliation of Dysphagia in Metastatic Esophageal Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Lorenzo Ferri, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
McGill University Health Center
Authority:
Canada: Ethics Review Committee
Study ID:
MalignantDysphagia
NCT ID:
NCT01366833
Start Date:
June 2011
Completion Date:
December 2013
Related Keywords:
- Malignant Dysphagia
- Esophageal Cancer
- Dysphagia
- Esophagus
- Cancer
- Esophageal Cancer
- Deglutition Disorders
- Esophageal Diseases
- Esophageal Neoplasms