Dose De-escalation Randomized Phase I/II Trial in Arrhythmia Radioablation for Ventricular Tachycardia: Single Fraction vs Three Fractions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Structural heart disease:
- •Ischemic cardiomyopathy
- •Non-ischemic cardiomyopathy
- •Hypertrophic cardiomyopathy
- •Refractory VT severity:
- •VT leading to ICD shock with minimum 3 episodes in any 3-month period without reversible cause;
- •Failed or intolerant to antiarrhythmic drug therapy (either amiodarone or ≥ 2 AADs) AND failed ablation (CA)
- •OR ablation (CA) contraindicated
- •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
排除标准
- •Age < 18 years
- •Pregnancy
- •Prior chest radiation therapy
研究组 & 干预措施
12 Gy Radiation Dose for 3 fractions (Arm 2 Group 1)
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)
干预措施: Radiation Therapy (Radiation)
10 Gy Radiation Dose for 3 fractions (Arm 2 Group 2)
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)
干预措施: Radiation Therapy (Radiation)
20 Gy Radiation Dose (Arm 1 Group 1)
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)
干预措施: Radiation Therapy (Radiation)
15 Gy Radiation Dose (Arm 1 Group 2)
Arm 1:
Group 2 (3 participants) - will receive a dose of 15 Gy in a single study intervention (one study intervention day)
干预措施: Radiation Therapy (Radiation)
10 Gy Radiation Dose (Arm 1 Group 3)
Arm 1:
Group 3 (3 participants) - will receive a dose of 10 Gy in a single study intervention (one study intervention day)
干预措施: Radiation Therapy (Radiation)
8Gy Radiation Dose for 3 fractions (Arm 2 Group 3)
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)
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes
时间窗: 6 weeks post treatment
Number of treatment-related serious adverse events (SAEs)
时间窗: 6 weeks post treatment
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.
Efficacy as measured by number of subjects with a reduction ≥ 60% (tracked by ICD recordings) ventricular tachycardia (VT) episodes
时间窗: 6 months before treatment
次要结局
- Number of ventricular tachycardia (VT) episodes(12 months)
- Number of subacute treatment side-effects(6 months post)
- Number of late Adverse events(2 year post)
- Overall survival(2 year post)
- Recurrence free survival(24 months post)
- Number of incidents of implantable cardiac device (ICD) shock(3 months post treatment)
- Number of Anti-Arrhythmic Drugs (AADs) administration(3 months post treatment)
- Number of ventricular tachycardia (VT) episodes(3 months post)
- Number of ventricular tachycardia (VT) episodes(6 months post)
- Number of subacute treatment side-effects(3 months post)
- Number of late Adverse events(1 year post)
- Overall survival(1 year post)
- Recurrence free survival(3 months post)
- Recurrence free survival(6 months post)
- Recurrence free survival(12 months post)
- Number of incidents of implantable cardiac device (ICD) shock(3 months before treatment)
- Number of Anti-Arrhythmic Drugs (AADs) administration(3 months before treatment)