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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.
Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder that arises from areas of diseased tissue in the heart. Treatment of VT can involve anti-arrhythmic drugs and catheter-based ablations. Unfortunately, despite multiple antiarrhythmic drugs, as well as the catheter-based ablation procedures, VT continues to persist in your case. At this point in time, The investigators believe that stereotactic body radiotherapy (SBRT) remains the only possible option to potentially treat VT. The investigators hypothesize that by administering SBRT at different dose levels and fractionation may achieve a better therapeutic ratio, defined as comparable efficacy with less risk of toxicity due to lower dose exposure to the normal tissue, including the heart vasculature, in patients when compared to VT patients who receive a dose of 25Gy in a single fraction which is the current treatment option.
This is a randomized dose de-escalation trial where the patients will be randomized in in one of the two experimental arms, receiving 1 single fraction OR 3 daily consecutive fractions of RT, and will be treated into a prespecified dose level group, based on the study development. The study includes three de-escalated consecutive dose level groups for each of two randomized treatment arms and there will be 3 patients per group and each group will receive a particular radiation treatment either as single treatments or three treatments.
The purpose of this treatment is to safely reduce episodes of VT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 Gy Radiation Dose (Arm 1 Group 1) | Experimental | 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) |
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| 15 Gy Radiation Dose (Arm 1 Group 2) | Experimental | Arm 1: Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day) |
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| 10 Gy Radiation Dose (Arm 1 Group 3) | Experimental | Arm 1: Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day) |
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| 12 Gy Radiation Dose for 3 fractions (Arm 2 Group 1) | Experimental | 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) |
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| 10 Gy Radiation Dose for 3 fractions (Arm 2 Group 2) | Experimental | 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes | 6 months before treatment | |
| Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes | 6 weeks post treatment | |
| Number of treatment-related serious adverse events (SAEs) | Safety: SAEs rate ≤ 30% defined using Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0) that could be treatment-related (possibly, probably, or definitely related to treatment) at 6 weeks after treatment is considered clinically acceptable. The SAEs are defined as any grade 3 toxicity requiring hospitalization or any grade 4 to 5 toxicity. | 6 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ventricular tachycardia (VT) episodes | 3 months post | |
| Number of ventricular tachycardia (VT) episodes | 6 months post | |
| Number of ventricular tachycardia (VT) episodes |
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Inclusion Criteria:
Age ≥ 18 years
Structural heart disease:
Refractory VT severity:
Ability to understand study protocol and to write informed consent
Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
Expected to remain available for at least 36 months after enrollment
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabiana Gregucci, M.D. | Contact | 646 962 3110 | fgr4002@med.cornell.edu | |
| Fereshteh Talebi, M.D. | Contact | 646 702 7830 | fet4007@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Silvia Formenti, M.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
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If participants are randomized to either Arm 1 or Arm 2, participants will be in one of the three groups. Each group will enroll 3 participants, based on a criteria of consecutive enrollment over time. After 6 weeks from the last treated participant in Group 1, there will be a review of safety and efficacy of the study intervention in the treated participants before enrolling participants in the next group. This review will continue until the 3rd participant in Group 3 is enrolled and treated. Subsequently the protocol will then move into the follow up phase.
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| 8Gy Radiation Dose for 3 fractions (Arm 2 Group 3) | Experimental | 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) |
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| Radiation Therapy | Radiation | Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day) |
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| Radiation Therapy | Radiation | Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day) |
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| Radiation Therapy | Radiation | Group 1 (3 participants) - will receive a dose of 12 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 36Gy) |
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| Radiation Therapy | Radiation | Group 2 (3 participants) - will receive a dose of 10 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 30Gy) |
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| Radiation Therapy | Radiation | Group 3 (3 participants) - will receive a dose of 8 Gy given over 3 days (Days 1, 2 and 3). (Total radiation dose = 24Gy) |
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| 12 months |
| Number of subacute treatment side-effects | Subacute treatment side effects, defined as any grade according to CTCAE criteria (version 5.0) | 3 months post |
| Number of subacute treatment side-effects | Subacute treatment side effects, defined as any grade according to CTCAE criteria (version 5.0) | 6 months post |
| Number of late Adverse events | Long term treatment side effects, defined as any grade according to CTCAE criteria (version 5.0) | 1 year post |
| Number of late Adverse events | Long term treatment side effects, defined as any grade according to CTCAE criteria (version 5.0) | 2 year post |
| Overall survival | Overall survival, defined as time calculated from treatment to death for any cause; | 1 year post |
| Overall survival | Overall survival, defined as time calculated from treatment to death for any cause; | 2 year post |
| Recurrence free survival | Recurrence free survival, defined as "time to VT storm" with VT storm defined as ≥ 3 VT/VF episodes leading to ICD therapy within 24 hours | 3 months post |
| Recurrence free survival | Recurrence free survival, defined as "time to VT storm" with VT storm defined as ≥ 3 VT/VF episodes leading to ICD therapy within 24 hours | 6 months post |
| Recurrence free survival | Recurrence free survival, defined as "time to VT storm" with VT storm defined as ≥ 3 VT/VF episodes leading to ICD therapy within 24 hours | 12 months post |
| Recurrence free survival | Recurrence free survival, defined as "time to VT storm" with VT storm defined as ≥ 3 VT/VF episodes leading to ICD therapy within 24 hours | 24 months post |
| Number of incidents of implantable cardiac device (ICD) shock | 3 months before treatment |
| Number of incidents of implantable cardiac device (ICD) shock | 3 months post treatment |
| Number of Anti-Arrhythmic Drugs (AADs) administration | Any reduction in Anti-Arrhythmic Drugs (AADs) administration | 3 months before treatment |
| Number of Anti-Arrhythmic Drugs (AADs) administration | Any reduction in Anti-Arrhythmic Drugs (AADs) administration | 3 months post treatment |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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