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

A Quality of Life Comparison in Patients With Malignant Dysphagia Treated With Either Self-Expanding Plastic Stents (SEPS) or Self-Expanding Metal Stents (SEMS)

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.

Study Overview

• Status: Withdrawn
• Conditions: Esophageal Cancer; Gastrointestinal Complications
• Intervention / Treatment: Procedure: quality-of-life assessment; Procedure: management of therapy complications

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231-2410
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome 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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Sanjay Jagannath, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2006
• Primary Completion (Actual): April 11, 2008
• Study Completion (Actual): April 11, 2008

Study Registration Dates

• First Submitted: September 6, 2006
• First Submitted That Met QC Criteria: September 6, 2006
• First Posted (Estimate): September 7, 2006

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: gastrointestinal complications; stage III esophageal cancer; squamous cell carcinoma of the esophagus; adenocarcinoma of the esophagus; recurrent esophageal cancer; stage IV esophageal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: J05109; CDR0000489157 (Registry Identifier: PDQ (Physician Data Query)); JHOC-J05109; NA_00001547 (Other Identifier: JHM IRB)