Esophageal Cancer, Gastrointestinal Complications
Conditions
Keywords
recurrent esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, squamous cell carcinoma of the esophagus, adenocarcinoma of the esophagus, gastrointestinal complications
Brief 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.
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.
Interventions
PROCEDUREmanagement of therapy complications
PROCEDUREquality-of-life assessment
Sponsors
National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Degree and duration of improvement of dysphagia | — |
| Stent-related morbidities | — |
| Time to event (time until first complication) | — |
| Cost effectiveness of each type of stent | — |
| Overall rate of mortality | — |
Countries
United States
Outcome results
None listed