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To Observe the Benefit of Adding Brachytherapy After CCRT on Resectable Esophageal Cancer Patients Without Surgery
Sponsor: Chang Gung Memorial Hospital
Summary
Clinical experience of adding intraluminal brachytherapy with traditional applicator after definitive concurrent chemoradiotherapy (CCRT) for local-regional thoracic esophageal cancer is limited due to high complication risk and non-superiority in survival. The innovative applicator can maximize the therapeutic efficacy by reducing dose inhomogeneity in the esophageal wall, which will translate into less over-dosing and less risk of the side effects of fistula or stenosis. The primary goal of this study by using new applicator is to observe the change in local tumor control rate, while secondary goals are treatment related toxicity, progression-free survival, and overall survival.
Official title: To Observe the Local Tumor Recurrence Rate of Adding Intraluminal Brachytherapy With Balloon Applicator After Standard Definitive Concurrent Chemoradiotherapy (CCRT) on Local-regional Thoracic Esophageal Cancer Patients Who Refused Surgery
Key Details
Gender
All
Age Range
20 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2022-03-30
Completion Date
2026-10-18
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Add-on Brachytherapy
Brachytherapy protocol starts within 2 weeks after consolidative EBRT, subjects who are enrolled will receive brachytherapy with specified balloon applicator. High-dose-rate (HDR) brachytherapy system will be used in the treatment, 5-Gy per fraction is delivered to the pre-treatment esophageal length of primary tumor(s), second treatment if applicable will be finished within 2 weeks after the first one, a total of 5-10Gy in 1-2 fractions will be delivered.
"BRAXX" Esophageal Brachytherapy Applicator
The device is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use.
Locations (1)
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan, Taiwan