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.
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 19, 2024
CompletedFirst Submitted
Initial submission to the registry
February 26, 2024
CompletedFirst Posted
Study publicly available on registry
April 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedApril 15, 2024
April 1, 2024
10 months
February 26, 2024
April 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months after completion of treatment
Secondary Outcomes (6)
To estimate overall response rate.
12 months after completion of treatment
To estimate distant metastasis rate.
12 months after completion of treatment
To estimate progression-free survival rate.
12 months after completion of treatment
To estimate overall survival status.
12 months after completion of treatment
To estimate toxicity analysis.
12 months after completion of treatment
- +1 more secondary outcomes
Study Arms (1)
Add-on of intraluminal brachytherapy with "BRAXX" Esophageal Brachytherapy Applicator.
EXPERIMENTALBrachytherapy 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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Pin-I Huang, Ph.D
Taipei Veterans General Hospital, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physcian, Division of Radiation Oncology, Department of Oncology
Study Record Dates
First Submitted
February 26, 2024
First Posted
April 15, 2024
Study Start
February 19, 2024
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
April 15, 2024
Record last verified: 2024-04