Optimal Management of Malignant Dysphagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01366833
Recruitment Status : Unknown
Verified June 2011 by McGill University Health Center.
Recruitment status was:  Not yet recruiting
First Posted : June 6, 2011
Last Update Posted : June 6, 2011
Information provided by:
McGill University Health Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Malignant Dysphagia Esophageal Cancer Radiation: Brachytherapy Procedure: Stent insertion Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Management of Malignant Dysphagia: Stent vs. Stent Plus Endoluminal Brachytherapy for the Palliation of Dysphagia in Metastatic Esophageal Cancer
Study Start Date : June 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Self-expanding stent alone
All patients in Arm A will receive self-expanding stent alone
Procedure: Stent insertion
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.

Experimental: Brachytherapy and Stent therapy Radiation: Brachytherapy
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.

Primary Outcome Measures :
  1. To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01366833

Contact: Myriam Martel, RN 514-934-1934

Canada, Quebec
McGill University Health Centre Not yet recruiting
Montreal, Quebec, Canada, H3G1A4
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Lorenzo Ferri, MD, PhD McGill University Health Center
Principal Investigator: Monisha Sudarshan, MD McGill University Health Center
Principal Investigator: Marc David, MD McGill University Health Center
Principal Investigator: David Roberge, MD McGill University Health Center
Principal Investigator: Serge Mayrand, MD McGill University Health Center
Principal Investigator: Kevin Waschke, MD McGill University Health Center
Principal Investigator: Eleanor Eckert, Nutritionist McGill University Health Center
Principal Investigator: Myriam Martel, RN McGill University Health Center

Responsible Party: Lorenzo Ferri, McGill University Health Centre Identifier: NCT01366833     History of Changes
Other Study ID Numbers: MalignantDysphagia
First Posted: June 6, 2011    Key Record Dates
Last Update Posted: June 6, 2011
Last Verified: June 2011

Keywords provided by McGill University Health Center:
Esophageal Cancer

Additional relevant MeSH terms:
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms