Optimal Management of Malignant Dysphagia

This study is not yet open for participant recruitment.

Verified June 2011 by McGill University Health Center

Sponsor:

Information provided by:

McGill University Health Center

ClinicalTrials.gov Identifier:

NCT01366833

First received: June 2, 2011

Last updated: June 3, 2011

Last verified: June 2011

History of Changes

Purpose

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	Intervention	Phase
Malignant Dysphagia Esophageal Cancer	Radiation: Brachytherapy Procedure: Stent insertion	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Palliative Care Swallowing Disorders

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:

To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	June 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366833

Contacts

Contact: Myriam Martel, RN

514-934-1934

myriam_martel@yahoo.ca

Locations

Canada, Quebec
McGill University Health Centre	Not yet recruiting
Montreal, Quebec, Canada, H3G1A4

Sponsors and Collaborators

McGill University Health Center

Investigators

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

More Information

No publications provided

Responsible Party:	Lorenzo Ferri, McGill University Health Centre
ClinicalTrials.gov Identifier:	NCT01366833 History of Changes
Other Study ID Numbers:	MalignantDysphagia
Study First Received:	June 2, 2011
Last Updated:	June 3, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:

Dysphagia
Esophagus
Cancer
Esophageal Cancer

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases

Otorhinolaryngologic Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013

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