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Sponsored by: |
Southeast University, China |
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Information provided by: | Southeast University, China |
ClinicalTrials.gov Identifier: | NCT00477841 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study |
Enrollment: | 60 |
Study Start Date: | April 2004 |
Study Completion Date: | December 2006 |
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.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China, Jiangsu | |
Zhongda Hospital, Southeast University | |
Nanjing, Jiangsu, China, 210009 |
Principal Investigator: | Gao-Jun Teng, MD. Ph.D | Zhongda Hospital, Southeast University |
Study ID Numbers: | 320106196208052017 |
Study First Received: | May 22, 2007 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00477841 |
Health Authority: | China: State Food and Drug Administration |
esophageal Cancer Dysphagia Stent interstitial brachytherapy |
Deglutition Disorders Digestive System Neoplasms Digestive System Diseases Esophageal disorder Gastrointestinal Diseases |
Head and Neck Neoplasms Esophageal Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Esophageal neoplasm |
Neoplasms Neoplasms by Site |