Optimal Management of Malignant Dysphagia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by McGill University Health Center.
Recruitment status was  Not yet recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 22, 2014