Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia
| Status: | Suspended |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | April 1, 2017 |
| End Date: | December 31, 2023 |
Stereotactic Ablative Radiotherapy (SABR) for Refractory Ventricular Tachycardia - a Phase I/II Study
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.
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.
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
We found this trial at
1
site
Los Angeles, California 90095
310-825-4321
Principal Investigator: Robert K Chin, MD, PhD
Phone: 310-825-6577
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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