RecruitingNot ApplicableNCT06365866

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

A Phase II Clinical Trial Evaluating the Efficacy of Adding Intraluminal Brachytherapy After Concurrent Chemoradiotherapy (CCRT) for Local-regional Thoracic Esophageal Cancer.

Sponsor

Taipei Veterans General Hospital, Taiwan

Enrollment

20 participants

Start Date

Feb 19, 2024

Study Type

INTERVENTIONAL

Conditions

Head and Neck Neoplasms Esophageal Neoplasms Neoplasms Neoplasms by Site Gastrointestinal Neoplasms Digestive System Diseases Gastrointestinal Diseases Digestive System Neoplasms Esophageal Diseases

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.

Eligibility

Min Age: 20 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether adding internal radiation (brachytherapy) after standard chemoradiation improves outcomes for people with esophageal cancer in the chest area. **You may be eligible if...** - You are between 20 and 85 years old with a performance status allowing treatment - You have been diagnosed with thoracic esophageal cancer (stages I–IV) confirmed by biopsy - You have completed a full course of chemoradiation (45–55 Gy) **You may NOT be eligible if...** - Your cancer has completely resolved after chemoradiation (per investigator's assessment) - You have distant spread of cancer beyond the local region - You have conditions that make additional radiation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

RADIATIONAdd-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.