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.

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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.

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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

Study is for people with:

Esophageal Cancer

Study ID:

NCT00372450

Recruitment Status:

Withdrawn

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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There is 1 Location for this study

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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States

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Study is for people with:

Esophageal Cancer

Study ID:

NCT00372450

Recruitment Status:

Withdrawn

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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