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

Esophageal Cancer Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00372450
• Other study ID #: J05109
• Secondary ID: CDR0000489157JHO
• Status: Withdrawn
• Phase: N/A
• Start date: December 2006
• Est. completion date: April 11, 2008

Study information

• Verified date: November 2008
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 11, 2008
• Est. primary completion date: April 11, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastrointestinal Complications

Intervention

Procedure:
• management of therapy complications

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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