The cARdiac Radiation Therapy Sparing (HEARTS) for Thoracic Cancers
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in left ventricular ejection fraction (LVEF)
研究概览
简要总结
The goal of this clinical trial is to compare a new way of using magnetic resonance-guided adaptive radiation therapy (MRgART) to the standard of care linear accelerator (LINAC) radiation treatment in people with cancer in the thoracic region near the heart.
The main question it aims to answer is whether MRgART affects the heart differently than LINAC.
Participants will:
- Receive radiation therapy
- Undergo MRIs and bloodwork
- Complete quality of life questionnaires
详细描述
This clinical trial, The cARdiac Radiation Therapy Sparing (HEARTS) trial, will compare MR-guided adaptive radiation therapy (MRgART) with substructure sparing to standard of care x-ray based linac RT with whole-heart dose metrics for patients with cancer in the thoracic region based on longitudinal changes in cardiac function using MRI, quality of life, cardiac waveforms, and blood biomarkers.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years at the time of consent.
- •Dosimetric eligibility criteria met using endpoints from QUANTEC (>10% of heart receives > 25 Gy) as determined through rapid auto-planning
- •Participants with histologically or cytologically proven AJCC, 8th edition including:
- •Stage IIB, IIIA, IIIB, IIIC, or IV non-operable non-small cell lung cancer
- •Limited stage small cell lung cancer, once daily treatment (excluding twice per day fractionation schemes). Stage I-III N0-2 disease esophageal/esophagogastric cancer
- •Stage II or III thymoma/thymic carcinoma
- •Other cancers in the thoracic region that meet the dosimetric and other clinical trial criteria, for example lymphoma sarcoma.
- •Participants must have a course of daily fractionated RT planned of at least 15 treatment fractions, typically ranging from 1.8 to 4 Gy/fraction
排除标准
- •Definitive clinical or radiologic evidence of metastatic disease with life expectancy <12 months
- •Prior thoracic radiotherapy significantly overlapping the heart region
- •Contraindications to MRI
- •Severe, active co-morbidity defined as follows: New York Heart Association Functional Classification III/IV are not eligible.
研究组 & 干预措施
MRgART radiation therapy
Participants randomized to this arm will receive magnetic resonance-guided adaptive radiation therapy (MRgART)
干预措施: MRgART (Radiation)
LINAC radiation therapy
Participants randomized to this arm will receive linear accelerator (LINAC) radiation therapy
干预措施: LINAC (Radiation)
结局指标
主要结局
Change in left ventricular ejection fraction (LVEF)
时间窗: Pre-treatment, 3 months post-treatment, 6 months post-treatment
Changes are measured between timepoints as determined by cardiac MRI. LVEF is calculated by dividing the left ventricular (LV) stroke volume (the amount of blood pumped out) by the end-diastolic volume (the amount of blood in the left ventricle before contraction) and multiplying by 100.
次要结局
- Change in right ventricular function (RVEF)(Pre-treatment, 3 months, 6 months post-treatment)
- Change in left and right ventricular (LV/RV) volumes(Pre-treatment, 3 months, 6 months post-treatment)
- Change in myocardial strain(Pre-treatment, 3 months, 6 months post-treatment)
- Change in T1 Mapping(Pre-treatment, 3 months, 6 months post-treatment)
- Change in extracellular volume fraction (ECV)(Pre-treatment, 3 months, 6 months post-treatment)
- Change in semi-quantitative perfusion(Pre-treatment, 3 months, 6 months post-treatment)
- Change in late gadolinium enhancement(Pre-treatment, 3 months, 6 months post-treatment)
- Change Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score(Baseline to 12 months post-treatment (up to 14 months))
- Change in Functional Assessment of Cancer Therapy - Lung (FACT-L) Score(Baseline to 12 months post-treatment (up to 14 months))
- Toxicity related to cancer(Baseline, mid-treatment, end of treatment, 3, 6,9, and 12 months post-treatment)
- Change in T2 mapping(Pre-treatment, 3 months, 6 months post-treatment)