Clinical trial NCT00372450: Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Esophageal Cancer
Gastrointestinal Complications
Keywords: recurrent esophageal cancer
stage III esophageal cancer
stage IV esophageal cancer
squamous cell carcinoma of the esophagus
adenocarcinoma of the esophagus
gastrointestinal complications
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-09-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
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
Secondary outcomes:
measure: Cost effectiveness of each type of stent
measure: Degree and duration of improvement of dysphagia
measure: Stent-related morbidities
measure: Time to event (time until first complication)
measure: Overall rate of mortality
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Sanjay Jagannath, MD
role: STUDY_CHAIR
References: