Optimal Management of Malignant Dysphagia

NCT01366833 | Terminated DMC

• 1 other identifier: MalignantDysphagia
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Dysphagia; Esophageal Cancer

Keywords

Dysphagia; Esophagus; Cancer; Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

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

  2 years

Study Arms (2)

Self-expanding stent alone

ACTIVE COMPARATOR

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

Procedure: Stent insertion

Brachytherapy and Stent therapy

EXPERIMENTAL

Radiation: Brachytherapy

Interventions

Brachytherapy RADIATION

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.

Brachytherapy and Stent therapy

Stent insertion PROCEDURE

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.

Self-expanding stent alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Expected life expectancy \< 3 months
• Inability to undergo stent insertion
• Siewert Type III gastroesophageal cancer
• Esophageal-Airway fistula

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3G1A4, Canada

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Deglutition Disorders; Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Lorenzo Ferri, MD, PhD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Monisha Sudarshan, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Marc David, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• David Roberge, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Serge Mayrand, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Kevin Waschke, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Eleanor Eckert, Nutritionist

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Myriam Martel, RN

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 6, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

CA (1)