Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Self-Expandable Esophageal Radiation Stent:a Randomized Controlled Trial in Patients With Advanced Esophageal Cancer

This study has been completed.
Sponsor:
Information provided by:
Southeast University, China
ClinicalTrials.gov Identifier:
NCT00477841
First received: May 22, 2007
Last updated: April 17, 2008
Last verified: May 2007
  Purpose

To determine the response to treatment with a novel esophageal stent loaded with 125I seeds for intraluminal brachytherapy versus a conventional covered stent in patients with advanced esophageal cancer.


Condition Intervention Phase
Esophageal Cancer
Procedure: Esophageal stent placement
Procedure: dysphagia scores
Procedure: complications of therapy
Procedure: survival time of therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • Relief of dysphagia measured by dysphagia scores, survival time from the interventional procedure to the last follow-up. [ Time Frame: Follow-up in intervals of 1, 3, 6 and 12 months after stent placement ]

Secondary Outcome Measures:
  • Successful rate of stent placement, Stent-related complications and morbidity, Overall rate of mortality [ Time Frame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement ]

Enrollment: 60
Study Start Date: April 2004
Study Completion Date: December 2006
Detailed Description:

Esophageal cancer is common in some areas , ranking as the fourth leading cause of death from cancer in China and sixth worldwide. Although the prognosis of surgical resection for esophageal cancer has been improved, more than 50% of such patients are inoperable and have to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, brachytherapy has previously been utilized. Recently, stent placement has been widely accepted to be an option for palliation of the symptoms due to the esophageal strictures. However, recurrence of the neoplastic stricture remains a challenge after stent placement. To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The technical feasibility and safety with this new stent has been demonstrated to be adequate in a healthy rabbit model. The current study is designed to demonstrate the preliminary results with this irradiation stent in patients with inoperable esophageal cancer compared to those using a conventional covered stent.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed primary cancer of esophagus,
  • Must be dysphagia caused by esophageal cancer,
  • Surgically inoperable, but may be metastatic,
  • Without esophageal fistulas,
  • Must be an inpatient at Zhongda Hospital,
  • Life expectancy is over 6 months,

Exclusion Criteria:

  • Esophageal fistulas,
  • Tracheal compression with symptoms,
  • WBC <2000/mm3 and Platelet count <50,000/mm3,
  • Concurrent therapies:surgery, chemotherapy,radiotherapy, Traditional Chinese Medicine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477841

Locations
China, Jiangsu
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Southeast University, China
Investigators
Principal Investigator: Gao-Jun Teng, MD. Ph.D Zhongda Hospital, Southeast University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00477841     History of Changes
Other Study ID Numbers: 320106196208052017
Study First Received: May 22, 2007
Last Updated: April 17, 2008
Health Authority: China: Food and Drug Administration

Keywords provided by Southeast University, China:
esophageal Cancer
Dysphagia
Stent
interstitial brachytherapy

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 24, 2014