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Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia
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.
Details
| Lead sponsor | University of California, Los Angeles |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 1 |
| Start date | Sat Apr 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Aug 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Refractory Ventricular Tachycardia
Interventions
- Stereotactic Ablative Radiotherapy (SABR)
Countries
United States