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

Southeast University, China

Status and phase

Completed

Phase 2

Conditions

Esophageal Cancer

Treatments

Procedure: Esophageal stent placement

Procedure: complications of therapy

Procedure: dysphagia scores

Procedure: survival time of therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00477841

320106196208052017

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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