Stereotactic Ablative Radiotherapy (SABR) for Refractory Ventricular Tachycardia - a Phase I/II Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- ICD (Implantable Cardioverter Defibrillator) Shock Free Survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
ICD (Implantable Cardioverter Defibrillator) Shock Free Survival
时间窗: 6 months
ICD (implantable cardioverter defibrillator) shock free survival at six months
Incidence of Salvage Definitive Anti-arrhythmia Therapy (Cardiac Transplant)
时间窗: 5 years
Incidence of salvage definitive anti-arrhythmia therapy (cardiac transplant) over 5 years.
次要结局
- Incidence of ICD Shocks(12 months post-SABR procedure)
- Incidence of Return of Ventricular Tachycardia Requiring Defibrillation, Intravenous Drug Therapy or Readmission to Hospital(5 years)
研究者
Robert K. Chin
Principal Investigator
University of California, Los Angeles