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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.
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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| brachytherapy with multichannel balloon applicator | Experimental | 6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoesophageal Brachytherapy | Device | Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Dose of Radiation Delivered to 90% of Tumor Volume (D90) | Percent of prescription dose received by 90% of PTV (planning target volume) | 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 | Up to 6 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Treatment Volume | Volume of tissue, both tumor plus normal tissue volume, receiving 100% of the prescription dose | Up to 6 cycles (6 weeks) of treatment |
| Dose of Radiation to Organ at Risk (Bronchus) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John F Greskovich, MD | Cleveland Clinic, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic, Case Comprehensive Cancer Center | Weston | Florida | 33331 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brachytherapy With Multichannel Balloon Applicator | 6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors Endoesophageal Brachytherapy: Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brachytherapy With Multichannel Balloon Applicator | 6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors Endoesophageal Brachytherapy: Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dose of Radiation Delivered to 90% of Tumor Volume (D90) | Percent of prescription dose received by 90% of PTV (planning target volume) | Number of participants who received treatment | Posted | Median | Full Range | percentage of Prescription dose | Up to 6 months of follow-up |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Brachytherapy With Multichannel Balloon Applicator | 6 channel balloon re-positioning, multichannel brachytherapy applicator used to deliver localized radiation therapy to esophageal tumors Endoesophageal Brachytherapy: Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death, NOS | General disorders | Systematic Assessment | disease progression and pneumonia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Greskovich | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | 1-866-223-8100 | taussigresearch@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2017 | Aug 10, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2017 | Aug 12, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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.
| 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. | 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. | 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. | 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 | 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 | Up to 6 cycles (6 weeks) of treatment |
| Number of Particiapants With Esophageal Stricture | Presence of an esophageal stricture | 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 | Up to 6 cycles (6 weeks) of treatment |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | 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 | Number of participants who received treatment | Posted | Mean | Full Range | percentage of volume | Up to 6 months of follow-up |
|
|
|
| Secondary | Radiation Treatment Volume | Volume of tissue, both tumor plus normal tissue volume, receiving 100% of the prescription dose | Number of Participants who received treatment | Posted | Median | Full Range | cc | Up to 6 cycles (6 weeks) of treatment |
|
|
|
| Secondary | 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. | Number of Participants who had tumors in proximity to the specified organ | Posted | Median | Full Range | Gy | Up to 6 months of follow-up |
|
|
|
| Secondary | 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. | Number of Participants who had tumors in proximity to the specified organ | Posted | Median | Full Range | Gy | Up to 6 months of follow-up |
|
|
|
| Secondary | 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. | Number of Participants who had tumors in proximity to the specified organ | Posted | Median | Full Range | Gy | Up to 6 months of follow-up |
|
|
|
| Secondary | 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. | All Participants who received treatment | Posted | Count of Participants | Participants | Up to 6 months of follow-up |
|
|
|
| Secondary | Number of Participants With Esophageal Ulceration | Presence of an ulceration of the mucosa in area of brachytherapy treatment | All Participants who received treatment | Posted | Count of Participants | Participants | Up to 6 cycles (6 weeks) of treatment |
|
|
|
| Secondary | Number of Participants With Esophageal Fistula | Presence of a fistula between the esophagus and trachea, mainstem bronchus or mediastinum | All Participants who received treatment | Posted | Count of Participants | Participants | Up to 6 cycles (6 weeks) of treatment |
|
|
|
| Secondary | Number of Particiapants With Esophageal Stricture | Presence of an esophageal stricture | All Participants who received treatment | Posted | Count of Participants | Participants | Up to 6 cycles (6 weeks) of treatment |
|
|
|
| Secondary | Number of Participants With the Need for Dilation | Number of participants with the need for esophageal dilation | All participants who received treatment | Posted | Count of Participants | Participants | Up to 6 cycles (6 weeks) of treatment |
|
|
|
| Post-Hoc | Number of Participants With Need for Stent Placement | Need for esophageal stent | Number of participants who received treatment | Posted | Count of Participants | Participants | Up to 6 cycles (6 weeks) of treatment |
|
|
|
| 5 |
| 7 |
| 5 |
| 7 |
| 0 |
| 7 |
|
| Death, NOS | General disorders | Systematic Assessment | disease progression with neutropenic fevers, RLL pneumonia, and sepsis |
|
| Death, NOS | General disorders | Systematic Assessment | hospice progressive weakness |
|
| Death, NOS | General disorders | Systematic Assessment | overall poor prognosis |
|
| Death, NOS | General disorders | Systematic Assessment | Due to intestinal issues |
|
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| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |