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.
Taipei Veterans General Hospital, Taiwan
20 participants
Feb 19, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Age of 20-85 years, with ECOG performance 0-2.
- Thoracic esophageal cancer with clinical stage I-IV and biopsy proof; patient with stage I-IV cervical esophageal cancer could be recruited in this trial according to Investigator's assessment.
- Complete CCRT with total doses of 45-55Gy to GTV via external beam radiotherapy (EBRT).
Exclusion Criteria6
- According to Investigator's assessment, patients with double cancer or recurrence could be recruited in this trial if they continue to receive systemic therapy.
- Patient with double cancer, esophageal cancer or recurrence who is scheduled for surgery treatment.
- Involvement of tracheal mucosa or bronchial mucosa.
- Stenosis of esophageal lumen that cannot be bypassed by the applicator after EBRT.
- The distribution of the lesions of interest exceeds 10cm range.
- The patient is participating in other clinical trials.
Interventions
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.
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)
View Full Details on ClinicalTrials.gov
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NCT06365866