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

NCT00372450 | Withdrawn

• 4 other identifiers: J05109CDR0000489157JHOC-J05109NA_00001547
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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 Outcomes (5)

• 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

Interventions

management of therapy complications PROCEDURE

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Sanjay Jagannath, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2006
• First Posted: September 7, 2006
• Study Start: December 1, 2006
• Primary Completion: April 11, 2008
• Study Completion: April 11, 2008
• Last Updated: March 20, 2019

Record last verified: 2008-11

Locations

US (1)