Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Conditions

Esophageal Cancer Gastrointestinal Complications

Interventions

management of therapy complicationsPROCEDURE

quality-of-life assessmentPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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