Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00372450
First received: September 6, 2006
Last updated: May 9, 2009
Last verified: November 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Esophageal Cancer Gastrointestinal Complications |
Procedure: management of therapy complications Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Supportive Care |
| 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) |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- 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 Outcome Measures:
- 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
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2006 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372450
Locations
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
| Study Chair: | Sanjay Jagannath, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00372450 History of Changes |
| Other Study ID Numbers: | CDR0000489157, JHOC-J05109, JHOC-NA_00001547 |
| Study First Received: | September 6, 2006 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent esophageal cancer stage III esophageal cancer stage IV esophageal cancer |
squamous cell carcinoma of the esophagus adenocarcinoma of the esophagus gastrointestinal complications |
Additional relevant MeSH terms:
|
Deglutition Disorders Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Pharyngeal Diseases |
Otorhinolaryngologic Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013