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CArdiac STereotactic Radiation Treatment for Ablation of ventRicular Tachycardia (CASTAR)

5. november 2026 oppdatert av: Cancer Research Antwerp

The investigator-initiated, CArdiac Stereotactic radiation Treatment for Ablation of ventRicular tachycardia (CASTAR) study will be conducted in patients with ventricular tachycardia (VT) which is either refractory to antiarrhythmic medication therapy in maximal dose or to catheter ablation or with contraindications to antiarrhythmic medication or catheter ablation.

The study is a non-randomized, multicenter, interventional study of cardiac SBRT, for which a total dose of 25 Gy will be delivered in a single fraction using volumetric modulated arc therapy (VMAT). The aim of the CASTAR study is to assess the feasibility and the safety of cardiac SBRT for the treatment of VT. Secondary objectives are efficacy, toxicity and QoL of cardiac SBRT for Ventricular tachycardia .

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The study will be conducted at multiple centers across Belgium. Twenty patients will be enrolled to the study. Interim analyses are planned to be performed when the first five or ten subjects have been treated. Participation in the study will comprise a screening period, where screening assessments must be completed before starting treatment. Eligible, consenting patients will then undergo SBRT, which is limited to a single dose delivery on one day. During SBRT, patients are closely monitored in accordance with the DEGRO guidelines for radiotherapy in patients with ICDs (Gauter-Fleckenstein 2015). After SBRT, patients will be closely monitored during a 3-5 days hospitalization. The post-treatment phase will start after patients are discharged from the hospital. Patients will be followed on regular basis to assess safety and efficacy of SBRT treatment.

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
    • Belgium
      • Antwerp, Belgium, Belgia, 2610
        • Rekruttering
        • ZAS Augustinus
        • Ta kontakt med:
        • Hovedetterforsker:
          • Ines Joye, PhD
      • Edegem, Belgium, Belgia, 2600
        • Rekruttering
        • UZA
        • Ta kontakt med:
        • Hovedetterforsker:
          • Johan Saenen, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients over the age of 18 with structural heart disease
  • Patients with ventricular tachycardia requiring intervention (e.g. an electrical shock or anti-tachycardia pacing via an Implantable Cardioverter Defibrillator (ICD)) which cannot be managed with medication or catheter ablation, or where there are contraindications to treatment with medication or catheter ablation.
  • Contraindications may exist due to comorbidities or due to the type or severity of the disease.
  • Informed consent to participate has been obtained from the patient or from his or her legal representative.

Exclusion Criteria:

  • Lack of evidence that the ventricular tachycardia is triggered by myocardial scarring (based on MRI, CT EAM).
  • Any contraindication to radiosurgery (e.g. inability to precisely define the target volume due to imaging artefacts caused by an LVAD)
  • Pregnancy
  • Previous radiotherapy that prevents the safe delivery of the dose.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: SBRT

A single radiation dose of 25 Gy is delivered to the VT target.
Stråling: Stereotactic body radiation therapy (SBRT)

Stereotactic body radiation therapy (SBRT): a single radiation dose of 25 Gy is delivered to the VT target.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility of SBRT for the treatment of ventricular tachycardia
Tidsramme: Day of SBRT treatment (Day 1)

Feasibility will be assessed as the successful implementation and completion of cardiac SBRT without interruption of treatment. SBRT consists of a single fraction of 25 Gy delivered to the ventricular tachycardia target.
Day of SBRT treatment (Day 1)
Safety of SBRT for the treatment of ventricular tachycardia.
Tidsramme: From SBRT treatment through 31 days after SBRT

Safety will be assessed by the incidence and severity of adverse events related to radiotherapy following cardiac SBRT. Adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
From SBRT treatment through 31 days after SBRT

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in ventricular tachycardia burden following SBRT
Tidsramme: 6 months before SBRT through 6 months after SBRT

The ventricular tachycardia (VT) burden will be assessed by the number of VT episodes recorded by ECG and implantable cardioverter-defibrillator (ICD) readouts. The number of VT episodes during the 6 months following SBRT will be compared with the number during the 6 months preceding SBRT. A 6-week blanking period immediately following SBRT will be taken into account in the analysis of VT recurrences.
6 months before SBRT through 6 months after SBRT
Time from SBRT to first VT recurrence
Tidsramme: From SBRT through 36 months after treatment

Time from SBRT treatment to the first documented recurrence of ventricular tachycardia, as determined from ICD readouts. A 6-week blanking period following SBRT will be considered in the analysis of VT recurrence.
From SBRT through 36 months after treatment
Time from SBRT to first sustained ventricular tachycardia or ICD shock
Tidsramme: From SBRT through 36 months after treatment

Time from SBRT treatment to the first occurrence of sustained ventricular tachycardia or the first appropriate ICD shock during follow-up.
From SBRT through 36 months after treatment
Time from SBRT to first ventricular tachycardia storm
Tidsramme: From SBRT through 36 months after treatment

Time from SBRT treatment to the first occurrence of a ventricular tachycardia storm during follow-up.
From SBRT through 36 months after treatment
Change in the number of electrical storms following SBRT
Tidsramme: 6 months before SBRT through 6 months after SBRT

The number of electrical storms occurring following SBRT will be compared with the number occurring before SBRT treatment.
6 months before SBRT through 6 months after SBRT
Change in anti-tachycardia pacing and ICD shocks following SBRT
Tidsramme: 6 months before SBRT through 6 months after SBRT

The number of anti-tachycardia pacing (ATP) interventions and ICD shocks following SBRT will be compared with the number occurring before SBRT treatment.
6 months before SBRT through 6 months after SBRT
Change in anti-arrhythmic medication use following SBRT
Tidsramme: From baseline through 36 months after SBRT

Anti-arrhythmic medication use will be assessed during follow-up. The type and dosage of anti-arrhythmic drugs will be collected to evaluate changes in the need for anti-arrhythmic treatment following SBRT.
From baseline through 36 months after SBRT
Overall survival following SBRT
Tidsramme: From SBRT through 36 months after treatment

Overall survival will be assessed from the date of SBRT treatment until death from any cause.
From SBRT through 36 months after treatment
Incidence of heart transplantation following SBRT
Tidsramme: From SBRT through 36 months after treatment

The number and proportion of participants requiring heart transplantation during follow-up will be assessed.
From SBRT through 36 months after treatment
Incidence of cardiac arrhythmic mortality following SBRT
Tidsramme: From SBRT through 36 months after treatment

The number and proportion of participants who die from a cardiac arrhythmic cause during follow-up will be assessed.
From SBRT through 36 months after treatment
Incidence of cardiac non-arrhythmic mortality following SBRT
Tidsramme: From SBRT through 36 months after treatment

The number and proportion of participants who die from a cardiac non-arrhythmic cause during follow-up will be assessed.
From SBRT through 36 months after treatment
Incidence and severity of acute radiation-related adverse events
Tidsramme: Through 90 days after SBRT

The incidence and severity of adverse events related to radiotherapy will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. Acute adverse events are defined according to the time period specified in the protocol.
Through 90 days after SBRT
Incidence and severity of late radiation-related adverse events
Tidsramme: The protocol defines late adverse events as those occurring more than 90 days after starting radiotherapy.

The incidence and severity of late adverse events related to radiotherapy will be assessed and graded according to NCI CTCAE version 5.0.
The protocol defines late adverse events as those occurring more than 90 days after starting radiotherapy.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cancer Research Antwerp

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. februar 2026

Primær fullføring (Antatt)

25. februar 2032

Studiet fullført (Antatt)

25. februar 2035

Datoer for studieregistrering

Først innsendt

20. oktober 2026

Først innsendt som oppfylte QC-kriteriene

5. november 2026

Først lagt ut (Faktiske)

12. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CTO22012GZA

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