Clinical trial NCT03349892: Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia
Official title: Stereotactic Ablative Radiotherapy (SABR) for Refractory Ventricular Tachycardia - a Phase I/II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractory Ventricular Tachycardia
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for catheter based RFA ablative therapy

* Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for cardiac sympathetic denervation therapy
* Documented ventricular arrhythmias refractory to or not a suitable candidate for cardiac transplantation
* Documented sustained ventricular arrhythmias refractory to or not a suitable candidate for additional medical management
* ICD in place with documented episodes recurrent VT despite best clinical management previous refusal of ICD with recurrent sustained ventricular arrhythmias
* If ischemic cardiomyopathy, myocardial infarction occurred more than one month prior to enrollment
* No history of prior radiotherapy to the chest
* Prescribed dose must be deliverable using SABR technique
* Age ≥ 18 years
* Karnofsky Performance Status (KPS) \> 70
* If a woman is of childbearing potential, a negative serum pregnancy test must be documented. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for at least 4 weeks after study treatment.
* Ability to understand and willingness to sign a written informed consent

Primary outcomes:
measure: ICD (Implantable Cardioverter Defibrillator) Shock Free Survival
timeFrame: 6 months
measure: Incidence of Salvage Definitive Anti-arrhythmia Therapy (Cardiac Transplant)
timeFrame: 5 years
Secondary outcomes:
measure: Incidence of Return of Ventricular Tachycardia Requiring Defibrillation, Intravenous Drug Therapy or Readmission to Hospital
timeFrame: 5 years
measure: Incidence of ICD Shocks
timeFrame: 12 months post-SABR procedure
Other outcomes:
measure: Incidence of Decline of LV Ejection Fraction by More Than 5% on Two Consecutive Echocardiograms
timeFrame: 5 years
measure: Incidence of Persistent Increase in Baseline Supplemental Oxygen Requirement by 1L for a Duration of >3 Months
timeFrame: 5 years
measure: Incidence of Steroid Use for Radiotherapy Related Indications
timeFrame: 5 years
measure: Overall Survival
timeFrame: Followed for 10 years +
Locations:
city: Los Angeles
country: United States
facility: UCLA Department of Radiation Oncology
state: California
Study officials:
References: