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


Phase 1
18 Years
N/A
Not Enrolling
Both
Malignant Dysphagia, Esophageal Cancer

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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

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