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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00372450
First received: September 6, 2006
Last updated: May 9, 2009
Last verified: November 2008

September 6, 2006
May 9, 2009
June 2006
June 2008   (final data collection date for primary 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
Not Provided
Complete list of historical versions of study NCT00372450 on ClinicalTrials.gov Archive Site
  • 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
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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.

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.

Interventional
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Allocation: Randomized
Primary Purpose: Supportive Care
  • Esophageal Cancer
  • Gastrointestinal Complications
  • Procedure: management of therapy complications
  • Procedure: quality-of-life assessment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
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June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00372450
CDR0000489157, JHOC-J05109, JHOC-NA_00001547
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Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Sanjay Jagannath, MD Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP