Esophageal Cancer Clinical Trial
Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer
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.
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.
Full 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.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Baltimore Maryland, 21231, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.