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Malignant Dysphagia | Optimal Management of Malignant Dysphagia

Malignant Dysphagia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Malignant Dysphagia

Esophageal Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Radiation:BrachytherapyPatients 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.

Procedure:Stent insertionAfter 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Self-expanding stent aloneAll patients in Arm A will receive self-expanding stent alone

Brachytherapy and Stent therapy

Study Status

Unknown status

Start Date: June 2011

Completed Date: December 2013

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Lorenzo Ferri, MD, PhD

Lead Sponsor: McGill University Health Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01366833

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