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Optimal Management of Malignant Dysphagia

Primary Purpose

Malignant Dysphagia, Esophageal Cancer

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Brachytherapy

Stent insertion

About this trial

This is an interventional supportive care trial for Malignant Dysphagia focused on measuring Dysphagia, Esophagus, Cancer, Esophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Self-expanding stent alone

Brachytherapy and Stent therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01366833

First Posted

June 2, 2011

Last Updated

October 18, 2023

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT01366833

Brief Title

Optimal Management of Malignant Dysphagia

Official Title

Management of Malignant Dysphagia: Stent vs. Stent Plus Endoluminal Brachytherapy for the Palliation of Dysphagia in Metastatic Esophageal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Terminated

Why Stopped

Low accrual

Study Start Date

June 2011 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Dysphagia, Esophageal Cancer

Keywords

Dysphagia, Esophagus, Cancer, Esophageal Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Self-expanding stent alone

Arm Type

Active Comparator

Arm Description

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

Arm Title

Brachytherapy and Stent therapy

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Brachytherapy

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Stent insertion

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lorenzo Ferri, MD, PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Monisha Sudarshan, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marc David, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David Roberge, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Serge Mayrand, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Kevin Waschke, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eleanor Eckert, Nutritionist

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Myriam Martel, RN

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

McGill University Health Centre

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G1A4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Optimal Management of Malignant Dysphagia

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