Optimal Management of Malignant Dysphagia

McGill University

Status: Terminated

Conditions: Esophageal Cancer; Malignant Dysphagia

Treatments: Procedure: Stent insertion; Radiation: Brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01366833

MalignantDysphagia

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Self-expanding stent alone

Active Comparator group

Description:

All patients in Arm A will receive self-expanding stent alone

Treatment:

Procedure: Stent insertion

Brachytherapy and Stent therapy

Experimental group

Treatment:

Radiation: Brachytherapy