Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-27 @ 7:36 PM
Study NCT ID:
NCT00372450
Status:
WITHDRAWN
Last Update Posted:
2019-03-20
First Post:
2006-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}, {'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'low accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2006-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-11', 'completionDateStruct': {'date': '2008-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2006-09-06', 'studyFirstSubmitQcDate': '2006-09-06', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'conditionsModule': {'keywords': ['recurrent esophageal cancer', 'stage III esophageal cancer', 'stage IV esophageal cancer', 'squamous cell carcinoma of the esophagus', 'adenocarcinoma of the esophagus', 'gastrointestinal complications'], 'conditions': ['Esophageal Cancer', 'Gastrointestinal Complications']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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).\n\nSecondary\n\n* 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.\n* Analyze effective palliation (degree and duration of improvement of dysphagia) in these patients.\n* Determine the individual rates of complication associated with each type of esophageal stent in these patients.\n\nOUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients undergo placement of a self-expanding metal stent on day 1.\n* 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.\n\nPROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary cancer of the esophagus or gastroesophageal junction\n\n * Squamous cell or other type\n* Diagnosis of malignant dysphagia\n* Disease deemed surgically inoperable, but may be any of the following:\n\n * Locally contained\n * Locally advanced\n * Metastatic\n * Unresponsive to previous chemoradiotherapy\n * Recurrent despite previous surgical resection\n* Must be either an inpatient OR outpatient at Johns Hopkins Hospital\n* No known tracheal compression by tumor burden\n\nPATIENT CHARACTERISTICS:\n\n* Karnofsky performance status 50-100%\n* Life expectancy ≥ 6 months\n* Platelet count \\> 50,000/mm³\n* INR \\< 1.5\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* Prior surgery, chemotherapy, biologic therapy, or radiotherapy allowed\n* No concurrent surgery, chemotherapy, biologic therapy, or radiotherapy'}, 'identificationModule': {'nctId': 'NCT00372450', 'briefTitle': 'Plastic Stents Compared With Metal Stents in Treating Patients With Malignant Dysphagia Caused by Esophageal Cancer or Gastroesophageal Junction Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'A Quality of Life Comparison in Patients With Malignant Dysphagia Treated With Either Self-Expanding Plastic Stents (SEPS) or Self-Expanding Metal Stents (SEMS)', 'orgStudyIdInfo': {'id': 'J05109'}, 'secondaryIdInfos': [{'id': 'CDR0000489157', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'JHOC-J05109'}, {'id': 'NA_00001547', 'type': 'OTHER', 'domain': 'JHM IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'management of therapy complications', 'type': 'PROCEDURE'}, {'name': 'quality-of-life assessment', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21231-2410', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Sanjay Jagannath, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}