Esophageal NeoplasmsNCT06365866
Evaluate the Efficacy of Adding Intraluminal Brachytherapy After CCRT for Local-regional Thoracic Esophageal Cancer.
A study testing "BRAXX" Esophageal Brachytherapy Applicator. and Add-on of intraluminal brachytherapy in people with Esophageal Neoplasms and Head and Neck Neoplasms, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Esophageal Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms
- What is being tested?
- "BRAXX" Esophageal Brachytherapy Applicator. and Add-on of intraluminal brachytherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Feb 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Pin-I Huang, Ph.D., +886 955-275-822, pihuang@vghtpe.gov.tw
Pin-I Huang, Ph.D.
About this study
Official title: A Phase II Clinical Trial Evaluating the Efficacy of Adding Intraluminal Brachytherapy After Concurrent Chemoradiotherapy (CCRT) for Local-regional Thoracic Esophageal Cancer.
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.
Read the detailed description
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.
- Prior to undergoing any study-specific procedure, patients must read and sign the current Ethics Committee/Institutional Review Board (IRB)-approved informed consent form. All on-study procedures are permitted within the visit window of ± 2 week. CT with contrast (no contrast if contraindicated) will be done at months 6 and 9; CT or PET/CT will be done at week 12 and month 12; and endoscopy with or without biopsy will be done at week 12, month 6, 9 and 12 for evaluation of tumor response; OPD follows up at week12, month 6, 9 and 12. A patient will be withdrawn from this study in the situation of any grade 4 toxicities. As for any adverse effects≧grade3, dose reduction, or dose delay according to the tolerability of individual patients is allowed. Grade 3 toxicity will cause the rest of the treatment (at least 1 week) until recovery to ≤grade 2 toxicity. If any patient can not tolerate a full course of brachytherapy, the total dose (EBRT+brachytherapy) can be reduced to 60Gy without violation of protocol. The management of adverse effects will follow general principles. Because tumor response is usually observed after completion of treatment, patients will not withdraw from the study because of no response. However, patients should be withdrawn from the study of (1) any grade 4 toxicity or (2) any unexpected cause of SAE that needs to discontinue radiation such as stroke, heart attack, accident, infection, bleeding…etc. Any failure observed during the post-treatment period will be documented, and patients should be withdrawn from the study, facilitating other treatment interventions.
- During this 12-month trial, any other cancer treatment (such as target therapy) and any non-cancer treatment that can increase adverse reactions within the treatment field are prohibited, so as not to affect treatment outcome or cause a change in side effects. The general management of symptoms or other non-cancer-related treatment is allowed, as long as physicians confirm that the interpretation of treatment outcome or side effects will not be influenced.
- The Investigator may use the data collected in this study for future research; which shall be consented by the Subject in the consent form.
- Conditions
- Esophageal Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms, Digestive System Diseases, Digestive System Neoplasms, Esophageal Diseases
- Being tested
- "BRAXX" Esophageal Brachytherapy Applicator., Add-on of intraluminal brachytherapy
- Keywords
- Brachytherapy, Esophageal cancer, External beam radiotherapy, Intraluminal brachytherapy, Survival
- Medical subject headings
- Esophageal Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms, Digestive System Diseases, Digestive System Neoplasms, Esophageal Diseases, Neoplasms by Site, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"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.
Add-on of intraluminal brachytherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: "BRAXX" Esophageal Brachytherapy Applicator.; Radiation: Add-on of intraluminal brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after completion of treatment
Secondary outcomes (6)
To estimate overall response rate.
The overall response rate was observed within 1 year.
Measured: 12 months after completion of treatment
To estimate distant metastasis rate.
Subjects' distant metastasis rate was observed within 1 year.
Measured: 12 months after completion of treatment
To estimate progression-free survival rate.
Subjects' progression-free survival rate was observed within 1 year.
Measured: 12 months after completion of treatment
To estimate overall survival status.
Subjects' overall survival status was observed within 1 year.
Measured: 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.
Measured: 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.
Measured: 3 months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start19 Feb 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Add-on treatment to standard treatment (fixed doses allowing dose reduction or dose delay according to the tolerability of individual patients); No control group.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Pin-I Huang, Taipei Veterans General Hospital, Taiwan
- Investigators
- Pin-I Huang, Ph.D, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365866
- Sponsor's protocol ID
- 2022-06-008B
- Status last verified
- Apr 2024
- First submitted
- 26 Feb 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial Evaluating the Efficacy of Adding Intraluminal Brachytherapy After Concurrent Chemoradiotherapy (CCRT) for Local-regional Thoracic Esophageal Cancer.
- ClinicalTrials.gov ID
- NCT06365866
- Acronym / sponsor ID
- 2022-06-008B
- Conditions
- Esophageal Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms, Digestive System Diseases, Digestive System Neoplasms, Esophageal Diseases
- Keywords
- Brachytherapy, Esophageal cancer, External beam radiotherapy, Intraluminal brachytherapy, Survival
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- Prior to undergoing any study-specific procedure, patients must read and sign the current Ethics Committee/Institutional Review Board (IRB)-approved informed consent form. All on-study procedures are permitted within the visit window of ± 2 week. CT with contrast (no contrast if contraindicated) will be done at months 6 and 9; CT or PET/CT will be done at week 12 and month 12; and endoscopy with or without biopsy will be done at week 12, month 6, 9 and 12 for evaluation of tumor response; OPD follows up at week12, month 6, 9 and 12. A patient will be withdrawn from this study in the situation of any grade 4 toxicities. As for any adverse effects≧grade3, dose reduction, or dose delay according to the tolerability of individual patients is allowed. Grade 3 toxicity will cause the rest of the treatment (at least 1 week) until recovery to ≤grade 2 toxicity. If any patient can not tolerate a full course of brachytherapy, the total dose (EBRT+brachytherapy) can be reduced to 60Gy without violation of protocol. The management of adverse effects will follow general principles. Because tumor response is usually observed after completion of treatment, patients will not withdraw from the study because of no response. However, patients should be withdrawn from the study of (1) any grade 4 toxicity or (2) any unexpected cause of SAE that needs to discontinue radiation such as stroke, heart attack, accident, infection, bleeding…etc. Any failure observed during the post-treatment period will be documented, and patients should be withdrawn from the study, facilitating other treatment interventions.
- During this 12-month trial, any other cancer treatment (such as target therapy) and any non-cancer treatment that can increase adverse reactions within the treatment field are prohibited, so as not to affect treatment outcome or cause a change in side effects. The general management of symptoms or other non-cancer-related treatment is allowed, as long as physicians confirm that the interpretation of treatment outcome or side effects will not be influenced.
- The Investigator may use the data collected in this study for future research; which shall be consented by the Subject in the consent form.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Add-on treatment to standard treatment (fixed doses allowing dose reduction or dose delay according to the tolerability of individual patients); No control group.
| Arm | Type | Receives |
|---|---|---|
| Add-on of intraluminal brachytherapy with "BRAXX" Esophageal Brachytherapy Applicator. | Experimental | Device: "BRAXX" Esophageal Brachytherapy Applicator., Radiation: Add-on of intraluminal brachytherapyBrachytherapy 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "BRAXX" Esophageal Brachytherapy Applicator.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. | Device | Add-on of intraluminal brachytherapy with "BRAXX" Esophageal Brachytherapy Applicator. |
| Add-on of intraluminal brachytherapyBrachytherapy 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. | Radiation | Add-on of intraluminal brachytherapy with "BRAXX" Esophageal Brachytherapy Applicator. |
Primary outcome
To estimate the local control rate at primary tumor site.
Time frame: 12 months after completion of treatment
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.
6 secondary outcomes
To estimate overall response rate.
Time frame: 12 months after completion of treatment
To estimate distant metastasis rate.
Time frame: 12 months after completion of treatment
To estimate progression-free survival rate.
Time frame: 12 months after completion of treatment
To estimate overall survival status.
Time frame: 12 months after completion of treatment
To estimate toxicity analysis.
Time frame: 12 months after completion of treatment
To estimate adverse event.
Time frame: 3 months after completion of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pin-I Huang, Ph.D principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "BRAXX" Esophageal Brachytherapy Applicator. and Add-on of intraluminal brachytherapy in people with Esophageal Neoplasms and Head and Neck Neoplasms, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pin-I Huang, Ph.D (+886-2-2875-7270, pihuang@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the local control rate at primary tumor site. (time frame: 12 months after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.