Clinical trial NCT00477841: Self-Expandable Esophageal Radiation Stent:a Randomized Controlled Trial in Patients With Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Keywords: esophageal Cancer
Dysphagia
Stent
interstitial brachytherapy
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2007-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Relief of dysphagia measured by dysphagia scores, survival time from the interventional procedure to the last follow-up.
timeFrame: Follow-up in intervals of 1, 3, 6 and 12 months after stent placement
Secondary outcomes:
measure: Successful rate of stent placement, Stent-related complications and morbidity, Overall rate of mortality
timeFrame: Follow-up in intervals of 1, 3, 6, and 12 months after stent placement
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Gao-Jun Teng, MD. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.