Radiation Therapy for Ventricular Tachycardia

Overseen By Fereshteh Talebi, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Pregnancy, Prior chest radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 week

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different radiation therapy doses to determine whether a single high dose or multiple smaller doses are more effective for treating refractory ventricular tachycardia (VT), a serious heart condition. VT occurs when the heart beats too fast due to faulty signals, and patients in this trial have not responded well to standard treatments like medications or procedures. The trial seeks participants with heart disease who have experienced frequent shocks from an implanted defibrillator (ICD) and have not found relief from drugs or procedures. As an unphased trial, this study offers a unique opportunity to explore new treatment options for those who have exhausted standard therapies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have failed or be intolerant to certain heart medications, which might imply changes to your medication routine. It's best to discuss this with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that radiation therapy for difficult-to-treat ventricular tachycardia (VT) is generally well-tolerated. In past studies, most patients who received this treatment experienced fewer VT episodes over a year. Importantly, these studies did not find any major safety issues. For example, in one study, out of 14 people treated, 12 survived beyond six weeks, and 10 lived for at least a year after treatment.

Different methods exist to deliver the radiation in this trial, but the treatment itself has been safely used in similar situations. The radiation doses being tested range from 10 to 20 Grays, administered either in one session or spread over three days. This approach is not new, and previous trials have shown it to be manageable for patients.

Overall, the evidence suggests that patients generally handle this treatment well, without serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using radiation therapy for ventricular tachycardia because it offers a novel approach compared to the standard options like antiarrhythmic medications and catheter ablation. This treatment stands out by using targeted radiation doses to potentially stabilize erratic heart rhythms, which could be less invasive than catheter ablation procedures. Additionally, radiation therapy could provide a quicker intervention with doses administered over just a few days, unlike the longer timelines often required for medications to take effect. This innovative method aims to offer a new, efficient way to manage ventricular tachycardia, potentially improving patient outcomes and reducing treatment times.

What evidence suggests that this trial's radiation therapy treatments could be effective for refractory ventricular tachycardia?

Research has shown that radiation therapy can treat stubborn cases of ventricular tachycardia (VT), especially when other treatments have failed. In this trial, participants will receive varying doses of radiation therapy to assess its effectiveness. One study found that patients who received stereotactic body radiotherapy experienced fewer VT episodes over a year. Additionally, a review of several studies found that this method, also known as stereotactic arrhythmia radioablation (STAR), can reduce the need for other treatments like anti-tachycardia pacing, which corrects irregular heartbeats. These findings suggest that radiation therapy might help manage heart rhythm problems in difficult-to-treat VT cases. ^{1 2 3 5 6}

Who Is on the Research Team?

Silvia Formenti, M.D.

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for patients with a heart condition called refractory ventricular tachycardia, which causes rapid heartbeat. These patients should not have responded well to standard treatments. Specific eligibility criteria are not provided, but typically include factors like age, overall health, and the severity of VT.

Inclusion Criteria

I have a type of heart muscle disease.

Ability to understand study protocol and to write informed consent

Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements

Exclusion Criteria

Pregnancy

I am under 18 years old.

I have had radiation therapy to my chest before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic body radiotherapy (SBRT) in either a single fraction or three consecutive fractions, depending on the randomized treatment arm

1 week

3 visits (in-person) for three fractions or 1 visit (in-person) for single fraction

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary safety assessment at 6 weeks post-treatment

6 weeks

1 visit (in-person)

Long-term Follow-up

Participants are monitored for long-term treatment side effects and overall survival

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Radiation Therapy

Trial Overview The study is testing radiation therapy as a treatment for VT. It compares two approaches: delivering one large dose at once versus splitting it into three smaller doses over time. The goal is to determine which method is more effective and safer for controlling this heart condition.

How Is the Trial Designed?

Group I: 8Gy Radiation Dose for 3 fractions (Arm 2 Group 3) Experimental Treatment 1 Intervention

Arm 2: Group 3 (3 participants) - will receive a dose of 8 Gy ("Gray", a measurement of radiation) given over 3 days (Days 1, 2 and 3). (Total radiation dose = 24Gy)

Group II: 20 Gy Radiation Dose (Arm 1 Group 1) Experimental Treatment 1 Intervention

Arm 1: Group 1 (3 participants) - will receive a dose of 20 Gy ("Gray", a measurement of radiation) in a single study intervention (one study intervention day)

Group III: 15 Gy Radiation Dose (Arm 1 Group 2) Experimental Treatment 1 Intervention

Arm 1: Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)

Group IV: 12 Gy Radiation Dose for 3 fractions (Arm 2 Group 1) Experimental Treatment 1 Intervention

Arm 2: Group 1 (3 participants) - will receive a dose of 12 Gy ("Gray", a measurement of radiation) given over 3 days (Days 1, 2 and 3). (Total radiation dose = 36Gy)

Group V: 10 Gy Radiation Dose for 3 fractions (Arm 2 Group 2) Experimental Treatment 1 Intervention

Arm 2: Group 2 (3 participants) - will receive a dose of 10 Gy ("Gray", a measurement of radiation) given over 3 days (Days 1, 2 and 3). (Total radiation dose = 30Gy)

Group VI: 10 Gy Radiation Dose (Arm 1 Group 3) Experimental Treatment 1 Intervention

Arm 1: Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

Intraoperative radiotherapy (IORT) was used in a study involving 1367 patients with 1400 tumors, showing a 5-year local recurrence rate of 5.98% for those receiving IORT only, which is comparable to other IORT studies but higher than standard whole breast radiation therapy (WBRT).

IORT offers benefits such as convenience and low complication rates, making it a viable option for patients meeting specific criteria, although the addition of WBRT was found to significantly reduce the risk of local recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). Silverstein, MJ., Epstein, MS., Chen, P., et al.[2022]

Cardiac stereotactic body radiotherapy (SBRT) has shown promising safety and effectiveness in treating refractory ventricular tachycardia (VT), with a significant reduction in VT burden of 98% at 6 months and 99% at 12 months after treatment in a study of 14 patients.

Despite some recurrence of VT in 33% of patients, SBRT demonstrated a favorable safety profile with no changes in ventricular function and a trend towards reduced amiodarone use, indicating its potential as a noninvasive treatment option for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Outcomes Following Stereotactic Body Radiotherapy for Refractory Ventricular Tachycardia. Arkles, J., Markman, T., Trevillian, R., et al.[2023]

In a study of 58 patients receiving high-dose radiation therapy for prostate cancer, using gold markers for image-guided radiation therapy (IGRT) reduced residual positioning errors, particularly in the vertical direction.

Despite the reduction in positioning errors with gold markers, the overall differences in dose distributions were moderate, suggesting that daily megavoltage CT (MVCT) alone could be a sufficient and valid alternative for IGRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosimetric implications of inter- and intrafractional prostate positioning errors during tomotherapy : Comparison of gold marker-based registrations with native MVCT. Wust, P., Joswig, M., Graf, R., et al.[2022]

Intraoperative radiotherapy (IORT) effectively delivers a single dose of radiation directly to the tumor bed during lumpectomy, minimizing exposure to surrounding healthy tissues.

The TARGIT A and ELIOT trials support the use of IORT for post-menopausal women with low to intermediate grade, lymph node negative, invasive ductal carcinoma, aligning with international guidelines for accelerated partial breast radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative radiotherapy in breast conserving surgery. Holmes, DR.[2022]

In a study of 10 advanced heart failure patients treated with stereotactic body radiation therapy (SBRT), there was a significant 69% reduction in the total duration of ventricular tachycardia (VT) detected by implantable cardioverter-defibrillators (ICDs) after treatment.

SBRT also led to a 68% reduction in the number of ICD shocks and a 48% decrease in antitachycardia pacing sequences, indicating that this noninvasive treatment can effectively reduce the burden of VT in patients who are refractory to standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience of stereotactic body radiation for refractory ventricular tachycardia in advanced heart failure patients. Lloyd, MS., Wight, J., Schneider, F., et al.[2021]

Image-guided radiation therapy (IGRT) has evolved significantly and is now widely used in routine clinical practice, emphasizing the importance of quality and patient safety in its application across various treatment techniques and anatomical sites.

The American Society for Radiation Oncology recommends a comprehensive quality-assurance program and an interdisciplinary team approach to ensure IGRT is performed safely and effectively, highlighting the need for ongoing updates to practice guidelines as technology advances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]

Image-guided radiotherapy (IGRT) can lead to significant additional radiation exposure for patients, with kV-CBCT delivering a median dose of around 30 mGy to the pelvis, while 2D-kV imaging provides the lowest dose at less than 1 mGy per image pair.

Optimizing imaging protocols can substantially reduce radiation doses, potentially decreasing exposure by up to a factor of 10, highlighting the importance of tailored imaging strategies based on patient anatomy and treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monte Carlo-based software for 3D personalized dose calculations in image-guided radiotherapy. Le Deroff, C., Berger, L., Bellec, J., et al.[2022]

Stereotactic body radiotherapy (SBRT) is being explored as a non-invasive treatment option for ventricular tachycardia (VT) caused by myocardial scarring, which is traditionally managed with antiarrhythmic drugs and catheter ablation that have limited effectiveness and potential side effects.

This review discusses the principles and early results from trials and case series that suggest SBRT may offer a promising alternative for patients with VT that does not respond to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Radiotherapy for the Management of Refractory Ventricular Tachycardia: Promise and Future Directions. Jumeau, R., Ozsahin, M., Schwitter, J., et al.[2020]

Intraoperative Radiotherapy (IORT) using Photon Radiosurgery Systems (PRS) shows stable performance over time, with average output levels maintained at 99.12% during testing, indicating reliability for clinical use.

The dosimetric characteristics of the x-ray sources were consistent, with measurements falling within manufacturer tolerances, suggesting that all four systems can effectively deliver radiation therapy with similar performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional intercomparison of intraoperative radiotherapy equipment - Photon Radiosurgery System. Armoogum, KS., Parry, JM., Souliman, SK., et al.[2023]

Intraoperative radiation therapy (IORT) allows for targeted radiation delivery during surgery, which can enhance local control of tumors while minimizing damage to surrounding healthy tissues, making it particularly beneficial for patients with locally advanced or recurrent cancers.

The addition of IORT to standard treatment regimens has shown improved local control and survival rates in various cancers, including rectal cancer and breast cancer, suggesting its potential for broader application in clinical practice as new, cost-effective devices become available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative radiation therapy. Willett, CG., Czito, BG., Tyler, DS.[2022]

Intraoperative radiation therapy (IORT) was assessed in 188 cancer patients, showing it to be a feasible and safe treatment option, with a 30-day postoperative mortality rate of only 3.2%.

While IORT was associated with a 28.7% rate of significant complications (grades III-IV), it was primarily used in conjunction with major surgeries and hyperthermic intraperitoneal chemotherapy, indicating its role in a comprehensive treatment strategy for various cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Intraoperative Radiation Therapy (IORT) in Multimodality Management of Cancer Patients: a Single Institution Experience. Elashwah, A., Alsuhaibani, A., Alzahrani, A., et al.[2023]

The study assessed the feasibility of using stereotactic body radiation therapy (SBRT) for treating ventricular tachycardia (VT) in one patient, showing that robust optimization techniques can significantly reduce radiation exposure to healthy heart tissues.

Using robust optimization, photon therapy reduced the average dose to the heart by about 25%, while proton therapy further decreased the dose to both the heart and left lung, highlighting the potential for safer treatment options for VT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton or photon radiosurgery for cardiac ablation of ventricular tachycardia? Breath and ECG gated robust optimization. Widesott, L., Dionisi, F., Fracchiolla, F., et al.[2021]

The STRA-MI-VT trial aims to evaluate the safety and efficacy of stereotactic body radiotherapy (SBRT) as a treatment for recurrent ventricular tachycardia (VT) in 15 patients with structural heart disease who are not candidates for catheter ablation.

If successful, SBRT could provide a less invasive alternative to traditional VT treatments, potentially improving patients' quality of life and survival rates over a follow-up period of up to 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

STRA-MI-VT (STereotactic RadioAblation by Multimodal Imaging for Ventricular Tachycardia): rationale and design of an Italian experimental prospective study. Carbucicchio, C., Jereczek-Fossa, BA., Andreini, D., et al.[2022]

In a study involving 42 cervical cancer patients, combining image-guided radiation therapy (IGRT) with high-dose-rate intracavitary brachytherapy (ICBT) improved the dose distribution to the tumor while reducing exposure to surrounding healthy tissues, such as the bladder and rectum.

The results showed that while the target dose to the high-risk clinical target volume (HRCTV) was similar between the combined treatment and optimized ICBT alone, the combined approach significantly increased the dose to intermediate-risk areas and decreased the dose to critical organs, suggesting a safer and more effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image guided radiation therapy boost in combination with high-dose-rate intracavitary brachytherapy for the treatment of cervical cancer. Wang, X., Li, J., Wang, P., et al.[2022]

In a study of 421 patients undergoing salvage radiotherapy (SRT) after prostate surgery, the use of advanced techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) significantly reduced the incidence of late gastrointestinal (GI) toxicities to 4.8%.

However, increasing the radiation dose to 68 Gy or more was linked to a higher risk of genitourinary (GU) toxicities, indicating that while advanced techniques can help minimize some side effects, higher doses may still pose risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. Tomita, N., Uchiyama, K., Mizuno, T., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37827346/

One-year outcomes after stereotactic body radiotherapy for ... Objective: The purpose of this study was to describe the safety and effectiveness of SBRT for VT in refractory to extensive ablation. Methods: After maximal ...

2. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)02912-6/fulltext

A systematic review and meta-analysis of prospective trials ... Data from prospective trials on stereotactic arrhythmia radioablation (STAR) for ventricular tachycardia (VT), also known as cardiac ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1547527123027820

One-year outcomes after stereotactic body radiotherapy for ... SBRT for a select group of patients who have failed maximal traditional therapy is associated with a reduction in treated VT episodes over the next 12 months. A ...

4. academic.oup.com academic.oup.com/europace/article/27/1/euae305/7931915

Stereotactic cardiac radiotherapy for refractory ventricular ... This study aims to assess the efficacy of cardiac SBRT in refractory VT by comparing the rates of VT episodes, anti-tachycardia pacing (ATP) therapies, and ...

5. redjournal.org redjournal.org/article/S0360-3016(25)06223-6/fulltext

Stereotactic Arrhythmia Radiation Therapy Versus Repeat ... Two ongoing studies comparing STAR versus CA outcomes include VT-ART (ventricular tachycardia ablation and radiotherapy, NCT06922214), a ...

6. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(23)02782-0/abstract

One-year outcomes after stereotactic body radiotherapy for ... Fourteen (93%) underwent treatment, with 12 (80%) surviving to the end of the 6-week period and 10 (67%) surviving to 12 months. From 6 week to ...