An interventional study of "BRAXX" Esophageal Brachytherapy Applicator. and Add-on of intraluminal brachytherapy in Esophageal Neoplasms, Head and Neck Neoplasms and Gastrointestinal Neoplasms, sponsored by Taipei Veterans General Hospital, Taiwan. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by Taipei Veterans General Hospital, Taiwan · Not applicable, Interventional, and Treatment
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.
Add-on of intraluminal brachytherapy with applicator:
Brachytherapy protocol starts within 12 weeks after EBRT (This is "week 1"). 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. GTV coverage D90 should equal 100% of prescription. It is NOT allowed to give concurrent chemotherapy on the days of HDR brachytherapy.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Brachytherapy protocol starts 3 weeks after EBRT (This is "week 1"). After transnasal insertion of the applicator into the esophagus, CT simulation scan(s) with a dummy source in place will be done for further planning procedures, including adjustment of the applicator and 3D treatment planning.
Device: "BRAXX" Esophageal Brachytherapy Applicator. · Radiation: Add-on of intraluminal brachytherapy
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.
To estimate the local control rate at primary tumor site.
Subjects will be followed every 3 months after treatment, EGD-endoscopy (± biopsy) and PET/ CT scans will be arranged in Months 3, 6, 9, and 12 to evaluate the tumor status.
Time frame: 12 months after completion of treatment
To estimate overall response rate.
The overall response rate was observed within 1 year.
Time frame: 12 months after completion of treatment
To estimate distant metastasis rate.
Subjects' distant metastasis rate was observed within 1 year.
Time frame: 12 months after completion of treatment
To estimate progression-free survival rate.
Subjects' progression-free survival rate was observed within 1 year.
Time frame: 12 months after completion of treatment
To estimate overall survival status.
Subjects' overall survival status was observed within 1 year.
Time frame: 12 months after completion of treatment
To estimate toxicity analysis.
All toxicities related to the treatment in this clinical trial will be recorded using the Common Toxicity Criteria version 5.0 developed by the National Cancer Institute.
Time frame: 12 months after completion of treatment
To estimate adverse event.
Adverse events of less severity are reported on case report forms and submitted with routine data submission. A submission of severe adverse effect (SAE) report includes every admission and ER visit of any reason within 3 months of treatment.
Time frame: 3 months after completion of treatment
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Taipei Veterans General Hospital, Taiwan