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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00477841
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : April 18, 2008
Information provided by:
Southeast University, China

Brief Summary:
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 or disease Intervention/treatment Phase
Esophageal Cancer Procedure: Esophageal stent placement Procedure: dysphagia scores Procedure: complications of therapy Procedure: survival time of therapy Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Study Start Date : April 2004
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00477841

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

Publications: Identifier: NCT00477841     History of Changes
Other Study ID Numbers: 320106196208052017
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: April 18, 2008
Last Verified: May 2007

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

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