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Stereotactic Ablative Radiotherapy for Refractory Ventricular Tachycardia

NCT ID: NCT03349892

Last Updated: 2021-11-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2019-08-06

Brief Summary

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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.

Detailed Description

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Conditions

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Refractory Ventricular Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stereotactic Ablation Treatment Arm

This is a single-arm, non-blinded study.

Group Type EXPERIMENTAL

Stereotactic Ablative Radiotherapy (SABR)

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Other Intervention Names

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external beam radiation

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Robert K. Chin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCLA Department of Radiation Oncology

Los Angeles, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Cardiac SABR

Identifier Type: -

Identifier Source: org_study_id