Esophageal CancerNCT00372450
Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer
A study testing management of therapy complications and quality-of-life assessment in people with Esophageal Cancer and Gastrointestinal Complications, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
RATIONALE: Placing a stent in the esophagus may lessen swallowing difficulties and improve quality of life in patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Esophageal Cancer, Gastrointestinal Complications
- What is being tested?
- management of therapy complications and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to 11 Apr 2008
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed primary cancer of the esophagus or gastroesophageal junction
- Squamous cell or other type
- Diagnosis of malignant dysphagia
- Disease deemed surgically inoperable, but may be any of the following:
- Locally contained
- Locally advanced
- Metastatic
- Unresponsive to previous chemoradiotherapy
- Recurrent despite previous surgical resection
- Must be either an inpatient OR outpatient at Johns Hopkins Hospital
- No known tracheal compression by tumor burden
PATIENT CHARACTERISTICS:
- Karnofsky performance status 50-100%
- Life expectancy ≥ 6 months
- Platelet count > 50,000/mm³
- INR < 1.5
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior surgery, chemotherapy, biologic therapy, or radiotherapy allowed
- No concurrent surgery, chemotherapy, biologic therapy, or radiotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: A Quality of Life Comparison in Patients With Malignant Dysphagia Treated With Either Self-Expanding Plastic Stents (SEPS) or Self-Expanding Metal Stents (SEMS)
RATIONALE: Placing a stent in the esophagus may lessen swallowing difficulties and improve quality of life in patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer.
PURPOSE: This randomized clinical trial is studying self-expanding plastic stents to see how well they work compared with self-expanding metal stents in treating patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer.
Read the detailed description
OBJECTIVES:
Primary
- Assess differences from baseline in health-related quality of life of patients with malignant dysphagia due to cancer of the esophagus or gastroesophageal junction palliated with self-expanding plastic stents (SEPS) compared to those who receive self-expanding metal stents (SEMS).
Secondary
- Perform a cost-effective analysis of each type of stent by independent evaluation of the rates of SEPS-related and SEMS-related morbidity that necessitates repeat endoscopic interventions and/or additional healthcare costs in these patients.
- Analyze effective palliation (degree and duration of improvement of dysphagia) in these patients.
- Determine the individual rates of complication associated with each type of esophageal stent in these patients.
OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo placement of a self-expanding metal stent on day 1.
- Arm II: Patients undergo placement of a self-expanding plastic stent on day 1. Health-related quality of life is assessed at baseline, 30 days, and 3 months.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
- Conditions
- Esophageal Cancer, Gastrointestinal Complications
- Being tested
- management of therapy complications, quality-of-life assessment
- Keywords
- recurrent esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus, gastrointestinal complications
- Medical subject headings
- Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
management of therapy complicationsProcedure or surgery
quality-of-life assessmentProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health-related quality of life from baseline to 30 days and 3 months after self-expanding plastic stent or self-expanding metal stent placement
Secondary outcomes (5)
Cost effectiveness of each type of stent
Degree and duration of improvement of dysphagia
Stent-related morbidities
Time to event (time until first complication)
Overall rate of mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startDec 2006 (estimated)
- Primary completion11 Apr 2008
- Study completion11 Apr 2008
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 Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sanjay Jagannath, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372450
- Sponsor's protocol ID
- J05109
- Other IDs
- CDR0000489157, JHOC-J05109, NA_00001547
- Status last verified
- Nov 2008
- First submitted
- 6 Sep 2006
- Last updated
- 20 Mar 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quality of Life Comparison in Patients With Malignant Dysphagia Treated With Either Self-Expanding Plastic Stents (SEPS) or Self-Expanding Metal Stents (SEMS)
- ClinicalTrials.gov ID
- NCT00372450
- Acronym / sponsor ID
- J05109
- Conditions
- Esophageal Cancer, Gastrointestinal Complications
- Keywords
- recurrent esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus, gastrointestinal complications
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2006 (estimated)
- Primary completion
- 11 Apr 2008 (actual)
- Study completion
- 11 Apr 2008 (actual)
- First posted
- 7 Sep 2006 (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.
RATIONALE: Placing a stent in the esophagus may lessen swallowing difficulties and improve quality of life in patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer.
PURPOSE: This randomized clinical trial is studying self-expanding plastic stents to see how well they work compared with self-expanding metal stents in treating patients with malignant dysphagia caused by esophageal cancer or gastroesophageal junction cancer.
Detailed description
OBJECTIVES:
Primary
- Assess differences from baseline in health-related quality of life of patients with malignant dysphagia due to cancer of the esophagus or gastroesophageal junction palliated with self-expanding plastic stents (SEPS) compared to those who receive self-expanding metal stents (SEMS).
Secondary
- Perform a cost-effective analysis of each type of stent by independent evaluation of the rates of SEPS-related and SEMS-related morbidity that necessitates repeat endoscopic interventions and/or additional healthcare costs in these patients.
- Analyze effective palliation (degree and duration of improvement of dysphagia) in these patients.
- Determine the individual rates of complication associated with each type of esophageal stent in these patients.
OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo placement of a self-expanding metal stent on day 1.
- Arm II: Patients undergo placement of a self-expanding plastic stent on day 1. Health-related quality of life is assessed at baseline, 30 days, and 3 months.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| management of therapy complications | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Change in health-related quality of life from baseline to 30 days and 3 months after self-expanding plastic stent or self-expanding metal stent placement
5 secondary outcomes
Cost effectiveness of each type of stent
Degree and duration of improvement of dysphagia
Stent-related morbidities
Time to event (time until first complication)
Overall rate of mortality
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
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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.
Sanjay Jagannath, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing management of therapy complications and quality-of-life assessment in people with Esophageal Cancer and Gastrointestinal Complications, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 20 Mar 2019. 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Change in health-related quality of life from baseline to 30 days and 3 months after self-expanding plastic stent or self-expanding metal stent placement. 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 20 Mar 2019.