Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

Overview

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.

Full Title of Study: “Stereotactic Ablative Radiotherapy (SABR) for Refractory Ventricular Tachycardia – a Phase I/II Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

Interventions

  • Radiation: 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.

Arms, Groups and Cohorts

  • Experimental: Stereotactic Ablation Treatment Arm
    • This is a single-arm, non-blinded study.

Clinical Trial Outcome Measures

Primary Measures

  • ICD (implantable cardioverter defibrillator) shock free survival
    • Time Frame: 6 months
  • Incidence of salvage definitive anti-arrhythmia therapy (cardiac transplant)
    • Time Frame: 5 years

Secondary Measures

  • Incidence of return of ventricular tachycardia requiring defibrillation, intravenous drug therapy or readmission to hospital
    • Time Frame: 5 years
  • Incidence of ICD shocks
    • Time Frame: 12 months post-SABR procedure

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, Los Angeles
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robert K. Chin, Principal Investigator – University of California, Los Angeles

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