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

NCT ID: NCT00477841

Last Updated: 2008-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2006-12-31

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.

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.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Esophageal stent placement

Intervention Type: PROCEDURE

dysphagia scores

Intervention Type: PROCEDURE

complications of therapy

Intervention Type: PROCEDURE

survival time of therapy

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southeast University, China

OTHER

Sponsor Role: lead

Principal Investigators

Gao-Jun Teng, MD. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Zhongda Hospital

Locations

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Countries

China

References

Guo JH, Teng GJ, Zhu GY, He SC, Deng G, He J. Self-expandable stent loaded with 125I seeds: feasibility and safety in a rabbit model. Eur J Radiol. 2007 Feb;61(2):356-61. doi: 10.1016/j.ejrad.2006.10.003. Epub 2006 Nov 7.

Reference Type: BACKGROUND

PMID: 17085003 (View on PubMed)

Other Identifiers

320106196208052017

Identifier Type: -

Identifier Source: org_study_id