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

NCT ID: NCT00372450

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-04-11

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.

Conditions

Esophageal Cancer; Gastrointestinal Complications

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

management of therapy complications

Intervention Type: PROCEDURE

quality-of-life assessment

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjay Jagannath, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

CDR0000489157

Identifier Type: REGISTRY

Identifier Source: secondary_id

JHOC-J05109

Identifier Type: -

Identifier Source: secondary_id

NA_00001547

Identifier Type: OTHER

Identifier Source: secondary_id

J05109

Identifier Type: -

Identifier Source: org_study_id