Radiation Therapy for Ventricular Tachycardia
Recruiting in Palo Alto (17 mi)
Overseen bySilvia Formenti, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Weill Medical College of Cornell University
Disqualifiers: Pregnancy, Prior chest radiation, others
No Placebo Group
Approved in 6 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a research study that aims to understand if giving a lower dose of treatment all at once is as effective and safe as dividing it into three smaller doses for patients with a heart condition called refractory ventricular tachycardia (VT). These patients have not exhibited positive responses to conventional medications or procedures. This study aims to explore whether an alternative approach could yield more beneficial outcomes.
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.
What data supports the effectiveness of the treatment Radiation Therapy for Ventricular Tachycardia?
Research on intraoperative radiation therapy (IORT) shows it can improve local control and survival rates in various cancers by delivering high doses of radiation directly to the tumor bed during surgery. This suggests that similar targeted radiation approaches might be effective for other conditions, like ventricular tachycardia, by precisely targeting affected areas while sparing healthy tissue.
12345Is radiation therapy generally safe for humans?
Radiation therapy techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) have been studied for safety, showing some risks of side effects such as gastrointestinal and genitourinary issues, but these are relatively low. Safety considerations are important and have been a focus of ongoing research to ensure patient safety in various treatments.
678910How is radiation therapy different from other treatments for ventricular tachycardia?
Radiation therapy, specifically stereotactic body radiotherapy (SBRT), is a non-invasive treatment that uses precise radiation to target areas of the heart causing ventricular tachycardia, unlike traditional treatments like antiarrhythmic drugs and catheter ablation, which can have limited effectiveness and potential side effects.
1112131415Eligibility Criteria
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 am 18 years old or older.
I have a type of heart muscle disease.
My VT has not improved with medication or a procedure, or I can't have the procedure.
+3 more
Exclusion Criteria
I am under 18 years old.
Pregnancy
I have had radiation therapy to my chest before.
Trial Timeline
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
Participant Groups
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.
6Treatment groups
Experimental Treatment
Group I: 8Gy Radiation Dose for 3 fractions (Arm 2 Group 3)Experimental Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Weill Cornell MedicineNew York, NY
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Who Is Running the Clinical Trial?
Weill Medical College of Cornell UniversityLead Sponsor
References
Functional intercomparison of intraoperative radiotherapy equipment - Photon Radiosurgery System. [2023]Intraoperative Radiotherapy (IORT) is a method by which a critical radiation dose is delivered to the tumour bed immediately after surgical excision. It is being investigated whether a single high dose of radiation will impart the same clinical benefit as a standard course of external beam therapy. Our centre has four Photon Radiosurgery Systems (PRS) currently used to irradiate breast and neurological sites.
Intraoperative radiation therapy. [2022]Intraoperative radiation therapy (IORT) is the delivery of irradiation at the time of an operation. This is performed by different techniques including intraoperative electron beam techniques and high-dose rate brachytherapy. IORT is usually given in combination with external-beam radiation therapy with or without chemotherapy and surgical resection. IORT excludes part or all dose-limiting sensitive structures, thereby increasing the effective dose to the tumor bed (and therefore local control) without significantly increasing normal tissue morbidity. Despite best contemporary therapy, high rates of local failure occur in patients with locally advanced or recurrent rectal cancer, retroperitoneal sarcoma, select gynecologic cancers, and other malignancies. The addition of IORT to conventional treatment methods has improved local control as well as survival in many disease sites in both the primary and locally recurrent disease settings. More recently, there has been interest in the use of IORT as a technique of partial breast irradiation for women with early breast cancer. Given newer and lower cost treatment devices, the use of IORT in clinical practice will likely grow, with increasing integration into the treatment of nonconventional malignancies. Optimally, phase III randomized trials will be carried out to prove its efficacy in these disease sites.
Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). [2022]Intraoperative radiotherapy (IORT) permits accurate delivery of radiation therapy directly to the tumor bed. We report local, regional, and distant recurrence data along with overall and breast cancer-specific survival for 1400 tumors treated with x-ray IORT.
The Use of Intraoperative Radiation Therapy (IORT) in Multimodality Management of Cancer Patients: a Single Institution Experience. [2023]Intraoperative radiation therapy (IORT) is a highly conformal type of radiation therapy given at time of surgery aiming for better tumor local control. It increases the tumor radiation dose without exceeding normal tissues tolerance doses.
Intraoperative radiotherapy in breast conserving surgery. [2022]Intraoperative radiotherapy (IORT) of the breast is the administration of a single fraction of radiation to the tumor bed while shielding low risk and uninvolved tissues from the effects of radiation. The TARGIT A and ELIOT trials demonstrate efficacy of IORT when administered at the time of lumpectomy to post-menopausal women with low to intermediate grade, lymph node negative, invasive ductal carcinoma, consistent with international guidelines defining suitable candidates for accelerated partial breast radiotherapy.
Image guided radiation therapy boost in combination with high-dose-rate intracavitary brachytherapy for the treatment of cervical cancer. [2022]The purpose of this study was to demonstrate the dosimetric and clinical feasibility of image guided radiation therapy (IGRT) combined with high-dose-rate (HDR) intracavitary brachytherapy (ICBT) to improve dose distribution in cervical cancer treatment.
Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]The safety and efficacy of dose-escalated radiotherapy with intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) remain unclear in salvage radiotherapy (SRT) after radical prostatectomy. We examined the impact of these advanced radiotherapy techniques and dose intensification on the toxicity of SRT. This multi-institutional retrospective study included 421 patients who underwent SRT at the median dose of 66 Gy in 2-Gy fractions. IMRT and IGRT were used for 225 (53%) and 321 (76%) patients, respectively. At the median follow-up of 50 months, the cumulative incidence of late grade 2 or higher gastrointestinal (GI) and genitourinary (GU) toxicities was 4.8% and 24%, respectively. Multivariate analysis revealed that the non-use of either IMRT or IGRT, or both (hazard ratio [HR] 3.1, 95% confidence interval [CI] 1.8-5.4, p
Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]This updated report on image guided radiation therapy (IGRT) is part of a series of consensus-based white papers previously published by the American Society for Radiation Oncology addressing patient safety. Since the first white papers were published, IGRT technology and procedures have progressed significantly such that these procedures are now more commonly used. The use of IGRT has now extended beyond high-precision treatments, such as stereotactic radiosurgery and stereotactic body radiation therapy, and into routine clinical practice for many treatment techniques and anatomic sites. Therefore, quality and patient safety considerations for these techniques remain an important area of focus.
Dosimetric implications of inter- and intrafractional prostate positioning errors during tomotherapy : Comparison of gold marker-based registrations with native MVCT. [2022]For high-dose radiation therapy (RT) of prostate cancer, image-guided (IGRT) and intensity-modulated RT (IMRT) approaches are standard. Less is known regarding comparisons of different IGRT techniques and the resulting residual errors, as well as regarding their influences on dose distributions.
Monte Carlo-based software for 3D personalized dose calculations in image-guided radiotherapy. [2022]Image-guided radiotherapy (IGRT) involves frequent in-room imaging sessions contributing to additional patient irradiation. The present work provided patient-specific dosimetric data related to different imaging protocols and anatomical sites.
Proton or photon radiosurgery for cardiac ablation of ventricular tachycardia? Breath and ECG gated robust optimization. [2021]Ventricular tachycardia (VT) is a life-threatening heart disorder. The aim of this preliminary study is to assess the feasibility of stereotactic body radiation therapy (SBRT) photon and proton therapy (PT) plans for the treatment of VT, adopting robust optimization technique for both irradiation techniques.
Stereotactic Radiotherapy for the Management of Refractory Ventricular Tachycardia: Promise and Future Directions. [2020]Ventricular tachycardia (VT) caused by myocardial scaring bears a significant risk of mortality and morbidity. Antiarrhythmic drug therapy (AAD) and catheter ablation remain the cornerstone of VT management, but both treatments have limited efficacy and potential adverse effects. Stereotactic body radiotherapy (SBRT) is routinely used in oncology to treat non-invasively solid tumors with high precision and efficacy. Recently, this technology has been evaluated for the treatment of VT. This review presents the basic underlying principles, proof of concept, and main results of trials and case series that used SBRT for the treatment of VT refractory to AAD and catheter ablation.
Clinical experience of stereotactic body radiation for refractory ventricular tachycardia in advanced heart failure patients. [2021]Stereotactic body radiation therapy (SBRT) has been shown to be effective in treating patients with refractory ventricular tachycardia.
One-Year Outcomes Following Stereotactic Body Radiotherapy for Refractory Ventricular Tachycardia. [2023]Cardiac stereotactic body radiotherapy (SBRT) has emerged as a promising noninvasive treatment for refractory ventricular tachycardia (VT).
STRA-MI-VT (STereotactic RadioAblation by Multimodal Imaging for Ventricular Tachycardia): rationale and design of an Italian experimental prospective study. [2022]Ventricular tachycardia (VT) is a life-threatening condition, which usually implies the need of an implantable cardioverter defibrillator in combination with antiarrhythmic drugs and catheter ablation. Stereotactic body radiotherapy (SBRT) represents a common form of therapy in oncology, which has emerged as a well-tolerated and promising alternative option for the treatment of refractory VT in patients with structural heart disease.