To deliver a single fraction stereotactic radiotherapy with acceptable toxicity and reduction in VT burden.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Acceptable acute toxicity defined by CTCAE v5.0. The incidence of serious
adverse events (SAEs, defined as >= grade 3) should be <33,33% within 90 days of
treatment.
Secondary outcome
To demonstrate the efficacy of STAR as defined by the reduction in VT burden
(number of ICD interventions and/or ATP, changes in antiarrhythmic medication),
and improvement in quality of life (PROM questionnaires). The reduction in VT
burden should be >= 50% after treatment compared to the 6 month period prior to
STAR. To record (potential) late treatment related toxicity after STAR.
Background summary
Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder.
Treatment is possible with anti-arrhythmic drugs, implantable
cardioverter-defibrillator and invasive catheter ablations. If VT is refractory
to these treatments a single fraction high-dose radiotherapy has recently shown
promising results.This study will implement this treatment at UMC Utrecht under
controlled conditions. The current study will also contribute to the STOPSTORM
data registry, where granular data from over 200 patients will be aggregated to
fine-tune the treatment.
Study objective
To deliver a single fraction stereotactic radiotherapy with acceptable toxicity
and reduction in VT burden.
Study design
Prospective feasibility study.
Intervention
A single fraction of 25 Gy will be given to the VT substrate. The VT substrate
will be defined on an individual patient basis by a clinical cardiac
electrophysiologist by combining different (imaging) examinations of the heart.
The radiation target will be delineated by the radiation oncologist in
consultation with the clinical cardiac electrophysiologist.
Study burden and risks
This study will only include patients refractory to the standard of care for
VT. Toxicity due to the stereotactic radiotherapy is the highest risk
associated with this treatment. To keep toxicity risk to a minimum, strict dose
constraints to the organs at risk (esophagus, lung, heart, chest wall) will be
applied using state of the art planning and treatment procedures. If the dose
to the organs at risk is exceeded, the treating radiation therapist should
decide if PTV coverage or OAR constraint will be compromised. To investigate
quality of life, validated questionnaires will be used.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
medication and ablation therapy refractory ventricular arrhythmia
Exclusion criteria
extreme arrhythmia substrate: polymorphic VT/VF, >3 distinct clinical VT
morphologies, >5 distinct induced VT morphologies during testing
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL76535.041.21 |
| OMON | NL-OMON24469 |