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RECRUITING
NCT06365866
NA

Evaluate the Efficacy of Adding Intraluminal Brachytherapy After CCRT for Local-regional Thoracic Esophageal Cancer.

Sponsor: Taipei Veterans General Hospital, Taiwan

View on ClinicalTrials.gov

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

Interventions

DEVICE

"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.

RADIATION

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