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Single arm, phase Ib/2a dose escalation study with an expansion cohort to determine the maximal tolerated dose (MTD) for stereotactic ablative radiotherapy of targets in the cardiac myocardium and to make a preliminary assessment of the efficacy of the treatment. The dose escalation will be guided by Time-to-Event Continual Reassessment Method (TITE-CRM) to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level that will be chosen as minimal dose of maximal effect. This design also allows for continual accrual of patients when delayed adverse events may be observed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Ablation Treatment Arm | Experimental | This is a single-arm, non-blinded study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Ablative Radiotherapy (SABR) | Radiation | A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning. |
| Measure | Description | Time Frame |
|---|---|---|
| ICD (Implantable Cardioverter Defibrillator) Shock Free Survival | ICD (implantable cardioverter defibrillator) shock free survival at six months | 6 months |
| Incidence of Salvage Definitive Anti-arrhythmia Therapy (Cardiac Transplant) | Incidence of salvage definitive anti-arrhythmia therapy (cardiac transplant) over 5 years. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Return of Ventricular Tachycardia Requiring Defibrillation, Intravenous Drug Therapy or Readmission to Hospital | Incidence of return of ventricular tachycardia requiring defibrillation, intravenous drug therapy or readmission to hospital over 5 years | 5 years |
| Incidence of ICD Shocks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Decline of LV Ejection Fraction by More Than 5% on Two Consecutive Echocardiograms | Incidence of decline of LV ejection fraction by more than 5% on two consecutive echocardiograms over 5 years | 5 years |
| Incidence of Persistent Increase in Baseline Supplemental Oxygen Requirement by 1L for a Duration of >3 Months |
Inclusion Criteria:
Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for catheter based RFA ablative therapy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Department of Radiation Oncology | Los Angeles | California | 90095-6951 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Ablation Treatment Arm | This is a single-arm, non-blinded study. Stereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Documented sustained ventricular arrhythmias refractory to or not suitable for cardiac transplantation, cardiac sympathetic denervation therapy, catheter based RFA ablative therapy or other medical management.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Ablation Treatment Arm | This is a single-arm, non-blinded study. Stereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning. |
| 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 | ICD (Implantable Cardioverter Defibrillator) Shock Free Survival | ICD (implantable cardioverter defibrillator) shock free survival at six months | Patients with refractory VT. | Posted | Count of Participants | Participants | 6 months |
|
28 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 | Stereotactic Ablation Treatment Arm | This is a single-arm, non-blinded study. Stereotactic Ablative Radiotherapy (SABR): A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert K. Chin, MD, PhD , Assistant Clinical Professor | University of California, Los Angeles | (310) 825-9771 | rkchin@mednet.ucla.edu |
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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 | Jun 21, 2018 | Jul 21, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
|
Incidence of ICD shocks 12 months post-SABR procedure |
| 12 months post-SABR procedure |
Incidence of persistent increase in baseline supplemental oxygen requirement by 1L for a duration of >3 months over 5 years |
| 5 years |
| Incidence of Steroid Use for Radiotherapy Related Indications | 5 years |
| Overall Survival | Followed for 10 years + |
| 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 | Incidence of Salvage Definitive Anti-arrhythmia Therapy (Cardiac Transplant) | Incidence of salvage definitive anti-arrhythmia therapy (cardiac transplant) over 5 years. | Single participant was lost to followup prior to 5-year assessment | Posted | 5 years |
|
|
| Secondary | Incidence of Return of Ventricular Tachycardia Requiring Defibrillation, Intravenous Drug Therapy or Readmission to Hospital | Incidence of return of ventricular tachycardia requiring defibrillation, intravenous drug therapy or readmission to hospital over 5 years | Study participant was lost to follow-up prior to 5-year assessment | Posted | 5 years |
|
|
| Secondary | Incidence of ICD Shocks | Incidence of ICD shocks 12 months post-SABR procedure | Subject was followed for 28 months. | Posted | Count of Participants | Participants | 12 months post-SABR procedure |
|
|
|
| Other Pre-specified | Incidence of Decline of LV Ejection Fraction by More Than 5% on Two Consecutive Echocardiograms | Incidence of decline of LV ejection fraction by more than 5% on two consecutive echocardiograms over 5 years | Subject was not followed for 5 years | Posted | 5 years |
|
|
| Other Pre-specified | Incidence of Persistent Increase in Baseline Supplemental Oxygen Requirement by 1L for a Duration of >3 Months | Incidence of persistent increase in baseline supplemental oxygen requirement by 1L for a duration of >3 months over 5 years | Subject was not followed for 5 years | Posted | 5 years |
|
|
| Other Pre-specified | Incidence of Steroid Use for Radiotherapy Related Indications | Subject was not followed for 5 years | Posted | 5 years |
|
|
| Other Pre-specified | Overall Survival | Subject was not followed for 10 years | Posted | Followed for 10 years + |
|
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| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |