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


N/A
18 Years
N/A
Open (Enrolling)
Both
Esophageal Cancer, Gastrointestinal Complications

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

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

Principal Investigator

Sanjay Jagannath, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000489157

NCT ID:

NCT00372450

Start Date:

June 2006

Completion Date:

Related Keywords:

  • Esophageal Cancer
  • Gastrointestinal Complications
  • recurrent esophageal cancer
  • stage III esophageal cancer
  • stage IV esophageal cancer
  • squamous cell carcinoma of the esophagus
  • adenocarcinoma of the esophagus
  • gastrointestinal complications
  • Deglutition Disorders
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410