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

Sponsor

Southeast University, China (Other)

Overall Status

Completed

CT.gov ID

NCT00477841

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single

Primary Purpose:

Treatment

Study Start Date :

Apr 1, 2004

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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