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

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00372450

Purpose

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.

Condition	Intervention
Cancer-Related Problem/Condition Esophageal Cancer	Procedure: management of therapy complications Procedure: quality-of-life assessment

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Swallowing Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Active Control
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)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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:

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

Estimated Enrollment:	90
Study Start Date:	June 2006
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372450

Locations

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

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Sanjay Jagannath, MD

Sidney Kimmel Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000489157, JHOC-J05109, JHOC-NA_00001547
Study First Received:	September 6, 2006
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00372450
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer

squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus
gastrointestinal complications

Study placed in the following topic categories:

Digestive System Neoplasms
Esophageal disorder
Gastrointestinal Diseases
Squamous cell carcinoma
Esophageal Neoplasms
Quality of Life
Recurrence
Carcinoma
Epidermoid carcinoma

Deglutition Disorders
Digestive System Diseases
Head and Neck Neoplasms
Carcinoma, squamous cell
Gastrointestinal Neoplasms
Esophageal Diseases
Carcinoma, Squamous Cell
Adenocarcinoma
Esophageal neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009