Overview

This trial is active, not recruiting.

Conditions esophageal cancer, gastrointestinal complications
Treatments management of therapy complications, quality-of-life assessment
Sponsor Sidney Kimmel Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date June 2006
End date June 2008
Trial size 90 participants
Trial identifier NCT00372450, CDR0000489157, JHOC-J05109, JHOC-NA_00001547

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose supportive care

Primary Outcomes

Measure
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
time frame:

Secondary Outcomes

Measure
Cost effectiveness of each type of stent
time frame:
Degree and duration of improvement of dysphagia
time frame:
Stent-related morbidities
time frame:
Time to event (time until first complication)
time frame:
Overall rate of mortality
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).