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Evaluate the Efficacy of Adding Intraluminal Brachytherapy After CCRT for Local-regional Thoracic Esophageal Cancer.
Sponsor: Taipei Veterans General Hospital, Taiwan
Summary
The purpose of this study is to observe the safety and effectiveness of the add-on of intraluminal brachytherapy with BRAXX esophageal brachytherapy applicator after definitive CCRT in patients with thoracic esophageal cancer.
Official title: A Phase II Clinical Trial Evaluating the Efficacy of Adding Intraluminal Brachytherapy After Concurrent Chemoradiotherapy (CCRT) for Local-regional Thoracic Esophageal Cancer.
Key Details
Gender
All
Age Range
20 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-02-19
Completion Date
2024-12
Last Updated
2024-04-15
Healthy Volunteers
No
Conditions
Interventions
"BRAXX" Esophageal Brachytherapy Applicator.
The device is intended for use with a commercially available after loader during brachytherapy. The purpose of the device is to deliver a radioactive source to the esophagus. This device is sterile, disposable, and single-use.
Add-on of intraluminal brachytherapy
Brachytherapy protocol starts within 12 weeks after EBRT. High-dose-rate (HDR) 5-Gy per fraction is delivered to GTV of esophageal tumor(s), second fraction (if applicable) to be done within 2 weeks after the first fraction, for a total of 5-10Gy in 1-2 fractions will be delivered.
Locations (1)
Taipei Veterans General Hospital
Taipei, Taiwan