A Phase II Clinical Trial Evaluating the Efficacy of Adding Intraluminal Brachytherapy After Concurrent Chemoradiotherapy (CCRT) for Local-regional Thoracic Esophageal Cancer.
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 85
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Taiwan
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Pin-I Huang, Ph.D
pihuang@vghtpe.gov.tw
+886-2-2875-7270
Time Frame
Start Date: 2024-02-19
Estimated Completion Date: 2024-12
Participants
Target number of participants: 20
Treatments
Experimental: Add-on of intraluminal brachytherapy with BRAXX Esophageal Brachytherapy Applicator.
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.
Related Therapeutic Areas
Sponsors
Leads: Taipei Veterans General Hospital, Taiwan