Malignant DysphagiaNCT01366833
Optimal Management of Malignant Dysphagia
A study testing Brachytherapy and Stent insertion in people with Malignant Dysphagia and Esophageal Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Dysphagia, Esophageal Cancer
- What is being tested?
- Brachytherapy and Stent insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Expected life expectancy < 3 months
- Inability to undergo stent insertion
- Siewert Type III gastroesophageal cancer
- Esophageal-Airway fistula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Malignant Dysphagia: Stent vs. Stent Plus Endoluminal Brachytherapy for the Palliation of Dysphagia in Metastatic Esophageal Cancer
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
- Being tested
- Brachytherapy, Stent insertion
- Keywords
- Dysphagia, Esophagus, Cancer, Esophageal Cancer
- Medical subject headings
- Esophageal Neoplasms, Deglutition Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrachytherapyRadiation
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.
Stent insertionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-expanding stent alone | Active comparator | All patients in Arm A will receive self-expanding stent alone Receives: Procedure: Stent insertion |
| Brachytherapy and Stent therapy | Experimental | Not described Receives: Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant DysphagiaStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Ferri, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Lorenzo Ferri, MD, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreMonisha Sudarshan, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreMarc David, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreDavid Roberge, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreSerge Mayrand, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreKevin Waschke, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreEleanor Eckert, Nutritionist, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreMyriam Martel, RN, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366833
- Sponsor's protocol ID
- MalignantDysphagia
- Status last verified
- Oct 2023
- First submitted
- 2 Jun 2011
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Malignant Dysphagia: Stent vs. Stent Plus Endoluminal Brachytherapy for the Palliation of Dysphagia in Metastatic Esophageal Cancer
- ClinicalTrials.gov ID
- NCT01366833
- Acronym / sponsor ID
- MalignantDysphagia
- Conditions
- Malignant Dysphagia, Esophageal Cancer
- Keywords
- Dysphagia, Esophagus, Cancer, Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-expanding stent alone | Active comparator | Procedure: Stent insertionAll patients in Arm A will receive self-expanding stent alone |
| Brachytherapy and Stent therapy | Experimental | Radiation: Brachytherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Expected life expectancy < 3 months
- Inability to undergo stent insertion
- Siewert Type III gastroesophageal cancer
- Esophageal-Airway fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrachytherapyPatients 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. | Radiation | Brachytherapy and Stent therapy |
| Stent insertionAfter 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. | Procedure or surgery | Self-expanding stent alone |
Primary outcome
To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorenzo Ferri, MD, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Monisha Sudarshan, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Marc David, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachytherapy and Stent insertion in people with Malignant Dysphagia and Esophageal Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the change in dysphagia score (0-4 Likert scale) measured at baseline and at 10 weeks (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.