Status:
WITHDRAWN
Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Gastrointestinal Complications
Eligibility:
All Genders
18-120 years
Phase:
NA
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...
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 wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00372450
Start Date
December 1 2006
End Date
April 11 2008
Last Update
March 20 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410