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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Add-on of intraluminal brachytherapy with "BRAXX" Esophageal Brachytherapy Applicator. | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "BRAXX" Esophageal Brachytherapy Applicator. | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate overall response rate. | The overall response rate was observed within 1 year. | 12 months after completion of treatment |
| To estimate distant metastasis rate. | Subjects' distant metastasis rate was observed within 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pin-I Huang, Ph.D | Contact | +886-2-2875-7270 | pihuang@vghtpe.gov.tw |
| Name | Affiliation | Role |
|---|---|---|
| Pin-I Huang, Ph.D | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
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Add-on treatment to standard treatment (fixed doses allowing dose reduction or dose delay according to the tolerability of individual patients); No control group.
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|
| Add-on of intraluminal brachytherapy | Radiation | 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. |
|
| 12 months after completion of treatment |
| To estimate progression-free survival rate. | Subjects' progression-free survival rate was observed within 1 year. | 12 months after completion of treatment |
| To estimate overall survival status. | Subjects' overall survival status was observed within 1 year. | 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. | 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. | 3 months after completion of treatment |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004066 | Digestive System Diseases |
| D004067 | Digestive System Neoplasms |
| D004935 | Esophageal Diseases |
| D009371 | Neoplasms by Site |
| D005767 | Gastrointestinal Diseases |
| D009369 | Neoplasms |
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