Esophageal CancerNCT03335813
Endoesophageal Brachytherapy for Patients With Esophageal Cancer
A study testing Endoesophageal Brachytherapy in people with Esophageal Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
Depending upon the cancer stage, esophageal cancer can be treated with surgery, chemotherapy, radiation therapy, or a combination of these modalities. Sometimes in addition to external radiation therapy or instead of external radiation therapy, select patients with esophageal cancer may benefit from localized… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Endoesophageal Brachytherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 8 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proved esophageal adenocarcinoma or squamous cell carcinoma
- Disease that can be encompassed in the radiotherapy treatment field
- Women of childbearing potential must practice adequate contraception
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Concurrent chemotherapy at the time of brachytherapy treatments
- Tracheal or bronchial involvement
- Cervical esophagus location
- Stenosis that cannot be bypassed or dilated to allow for applicator placement
- Not willing or unable to provide informed consent
- History of esophageal fistula
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Weston, Florida, 33331
About this study
Official title: Endoesophageal Brachytherapy for Patients With Esophageal Cancer: A Balloon Repositioning, Multichannel Radiation Applicator for Optimizing Treatment Delivery
Depending upon the cancer stage, esophageal cancer can be treated with surgery, chemotherapy, radiation therapy, or a combination of these modalities. Sometimes in addition to external radiation therapy or instead of external radiation therapy, select patients with esophageal cancer may benefit from localized radiation to the tumor, called esophageal brachytherapy. There are many different radiation techniques and delivery approaches for this type of specialized radiation therapy, and the purpose of this document is to provide a written summary of an innovative delivery method.
Read the detailed description
Primary Objective Pilot study of multichannel endoesophageal brachytherapy applicator to determine dose distribution and conformality of a 6 channel balloon repositioning applicator.
Secondary Objective(s)
- To collect data in order to show how the 6-tube endoesophageal brachytherapy technique will be an improvement (more conformed dose distribution) over a previously designed 3-tube endoesophageal brachytherapy technique in patients who are candidates for esophageal brachytherapy
- To evaluate acute toxicity of novel endoesophageal brachytherapy applicator.
Study Design
This innovative study will be an improvement over a previously designed 3-tube endoesophageal brachytherapy technique in patients who are candidates for esophageal brachytherapy. The brachytherapy planning process will utilize a novel multichannel balloon applicator.
The initial treatment session will occur after the patient has been found to be eligible, the consent form has been completed, and the treatment plan has been created. The patient will undergo subsequent weekly treatments for 3 to 6 weeks after the initial treatment.
The subject will be expected to participate in the trial throughout its entirety. The participation period is 6 months of which the patient will be evaluated and seen at months 3 and 6.
- Conditions
- Esophageal Cancer
- Being tested
- Endoesophageal Brachytherapy
- Keywords
- brachytherapy, multichannel balloon applicator
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoesophageal BrachytherapyDevice
Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation
| Study group | Role | What they receive |
|---|---|---|
| brachytherapy with multichannel balloon applicator | Experimental | 6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors Receives: Device: Endoesophageal Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose of Radiation Delivered to 90% of Tumor Volume (D90)
Percent of prescription dose received by 90% of PTV (planning target volume)
Measured: Up to 6 months of follow-up
Percent Volume of the Tumor Receiving the Prescription Dose (V100)
Percent volume of the tumor receiving 100% of the prescription dose calculated as the mean from the total weekly HDR brachytherapy treatment plans
Measured: Up to 6 months of follow-up
Secondary outcomes (9)
Radiation Treatment Volume
Volume of tissue, both tumor plus normal tissue volume, receiving 100% of the prescription dose
Measured: Up to 6 cycles (6 weeks) of treatment
Dose of Radiation to Organ at Risk (Bronchus)
Dose to 1cc volume of the trachea-mainstem bronchus calculated as the mean dose from the total weekly HDR brachytherapy treatment plans for the 4 participants who had tumors in proximity to the trachea or mainstem bronchus.
Measured: Up to 6 months of follow-up
Dose of Radiation to Organ at Risk (Heart)
Dose to 1 cc volume of the heart calculated as the mean dose from the total weekly HDR brachytherapy treatment plans for the 4 participants who had tumors in proximity to the heart.
Measured: Up to 6 months of follow-up
Dose of Radiation to Organ at Risk (Aorta)
Dose to 1 cc volume of the aorta calculated as the mean dose from the total weekly HDR brachytherapy treatment plans for the 6 participants who had tumors in proximity to the aorta.
Measured: Up to 6 months of follow-up
Tumor Response Based on Resist Criteria
Tumor response determined by endoscopic evaluation of tumor at time of last brachytherapy treatment. Endoscopic CR is defined as no visible tumor at end of treatment -on endoscopy exam and PR is defined as a persistent tumor at the end of treatment.
Measured: Up to 6 months of follow-up
Number of Participants With Esophageal Ulceration
Presence of an ulceration of the mucosa in area of brachytherapy treatment
Measured: Up to 6 cycles (6 weeks) of treatment
Number of Participants With Esophageal Fistula
Presence of a fistula between the esophagus and trachea, mainstem bronchus or mediastinum
Measured: Up to 6 cycles (6 weeks) of treatment
Number of Particiapants With Esophageal Stricture
Presence of an esophageal stricture
Measured: Up to 6 cycles (6 weeks) of treatment
Number of Participants With the Need for Dilation
Number of participants with the need for esophageal dilation
Measured: Up to 6 cycles (6 weeks) of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start6 Mar 2018
- Primary completion14 Nov 2020
- Study completion8 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John F Greskovich, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335813
- Sponsor's protocol ID
- CASE5217
- Status last verified
- May 2022
- First submitted
- 3 Nov 2017
- Last updated
- 9 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoesophageal Brachytherapy for Patients With Esophageal Cancer: A Balloon Repositioning, Multichannel Radiation Applicator for Optimizing Treatment Delivery
- ClinicalTrials.gov ID
- NCT03335813
- Acronym / sponsor ID
- CASE5217
- Conditions
- Esophageal Cancer
- Keywords
- brachytherapy, multichannel balloon applicator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 14 Nov 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Posted 9 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Depending upon the cancer stage, esophageal cancer can be treated with surgery, chemotherapy, radiation therapy, or a combination of these modalities. Sometimes in addition to external radiation therapy or instead of external radiation therapy, select patients with esophageal cancer may benefit from localized radiation to the tumor, called esophageal brachytherapy. There are many different radiation techniques and delivery approaches for this type of specialized radiation therapy, and the purpose of this document is to provide a written summary of an innovative delivery method.
Detailed description
Primary Objective Pilot study of multichannel endoesophageal brachytherapy applicator to determine dose distribution and conformality of a 6 channel balloon repositioning applicator.
Secondary Objective(s)
- To collect data in order to show how the 6-tube endoesophageal brachytherapy technique will be an improvement (more conformed dose distribution) over a previously designed 3-tube endoesophageal brachytherapy technique in patients who are candidates for esophageal brachytherapy
- To evaluate acute toxicity of novel endoesophageal brachytherapy applicator.
Study Design
This innovative study will be an improvement over a previously designed 3-tube endoesophageal brachytherapy technique in patients who are candidates for esophageal brachytherapy. The brachytherapy planning process will utilize a novel multichannel balloon applicator.
The initial treatment session will occur after the patient has been found to be eligible, the consent form has been completed, and the treatment plan has been created. The patient will undergo subsequent weekly treatments for 3 to 6 weeks after the initial treatment.
The subject will be expected to participate in the trial throughout its entirety. The participation period is 6 months of which the patient will be evaluated and seen at months 3 and 6.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brachytherapy with multichannel balloon applicator | Experimental | Device: Endoesophageal Brachytherapy6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy-proved esophageal adenocarcinoma or squamous cell carcinoma
- Disease that can be encompassed in the radiotherapy treatment field
- Women of childbearing potential must practice adequate contraception
- Subjects must have the ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (6 listed)
- Concurrent chemotherapy at the time of brachytherapy treatments
- Tracheal or bronchial involvement
- Cervical esophagus location
- Stenosis that cannot be bypassed or dilated to allow for applicator placement
- Not willing or unable to provide informed consent
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 |
|---|---|---|
| Endoesophageal BrachytherapyBalloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation | Device | brachytherapy with multichannel balloon applicator |
Primary outcome
Dose of Radiation Delivered to 90% of Tumor Volume (D90)
Time frame: Up to 6 months of follow-up
Percent of prescription dose received by 90% of PTV (planning target volume)
Percent Volume of the Tumor Receiving the Prescription Dose (V100)
Time frame: Up to 6 months of follow-up
Percent volume of the tumor receiving 100% of the prescription dose calculated as the mean from the total weekly HDR brachytherapy treatment plans
9 secondary outcomes
Radiation Treatment Volume
Time frame: Up to 6 cycles (6 weeks) of treatment
Dose of Radiation to Organ at Risk (Bronchus)
Time frame: Up to 6 months of follow-up
Dose of Radiation to Organ at Risk (Heart)
Time frame: Up to 6 months of follow-up
Dose of Radiation to Organ at Risk (Aorta)
Time frame: Up to 6 months of follow-up
Tumor Response Based on Resist Criteria
Time frame: Up to 6 months of follow-up
Number of Participants With Esophageal Ulceration
Time frame: Up to 6 cycles (6 weeks) of treatment
Number of Participants With Esophageal Fistula
Time frame: Up to 6 cycles (6 weeks) of treatment
Number of Particiapants With Esophageal Stricture
Time frame: Up to 6 cycles (6 weeks) of treatment
Number of Participants With the Need for Dilation
Time frame: Up to 6 cycles (6 weeks) of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John F Greskovich, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoesophageal Brachytherapy in people with Esophageal Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 9 Jun 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose of Radiation Delivered to 90% of Tumor Volume (D90) (time frame: Up to 6 months of follow-up). The study lists 2 primary outcomes in all. 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 9 Jun 2022.