A Quality of Life Comparison in Patients With Malignant Dysphagia Treated With Either Self-Expanding Plastic Stents (SEPS) or Self-Expanding Metal Stents (SEMS)
Data Collection
Esophageal Squamous Cell Carcinoma+12
+ Carcinoma
+ Carcinoma, Squamous Cell
Supportive Care Study
Summary
Study start date: December 1, 2006
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, United StatesOpen Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Google Maps