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

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ClinicalTrials.gov Identifier: NCT00372450
Recruitment Status : Withdrawn (low accrual)
First Posted : September 7, 2006
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.


Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastrointestinal Complications Procedure: management of therapy complications Procedure: quality-of-life assessment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Primary Purpose: Supportive Care
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)
Estimated Study Start Date : December 2006
Actual Primary Completion Date : April 11, 2008
Actual Study Completion Date : April 11, 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  1. Cost effectiveness of each type of stent
  2. Degree and duration of improvement of dysphagia
  3. Stent-related morbidities
  4. Time to event (time until first complication)
  5. Overall rate of mortality


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372450


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

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00372450     History of Changes
Other Study ID Numbers: J05109
CDR0000489157 ( Registry Identifier: PDQ (Physician Data Query) )
JHOC-J05109
NA_00001547 ( Other Identifier: JHM IRB )
First Posted: September 7, 2006    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: November 2008
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
recurrent esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus
gastrointestinal complications
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases