Esophageal Cancer Stage I-III, Esophagogastric Cancer Stage I-III, Non-Small Cell Lung Cancer (Stage III), Other Cancers in the Thoracic Region, Thymoma and Thymic Carcinoma Stage II-III
Conditions
Brief summary
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
Detailed description
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.
Interventions
RADIATIONMRgART
Magnetic Resonance-guided Adaptive Radiation Therapy (MRgART) is a form of MRgRT that incorporates daily adaptive planning, or making a new treatment plan each treatment, and real-time imaging during treatment delivery.
RADIATIONLINAC
Daily 3D x-ray scans will be obtained for radiation delivery to confirm tumor and organ at risk placement.
Sponsors
University of Wisconsin, Madison
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular ejection fraction (LVEF) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in right ventricular function (RVEF) | Pre-treatment, 3 months, 6 months post-treatment | Changes are measured between timepoints as determined by cardiac MRI. RVEF is calculated by dividing the right ventricular (RV) stroke volume (the amount of blood pumped out) by the end-diastolic volume (the amount of blood in the right ventricle before contraction) and multiplying by 100. |
| Change in left and right ventricular (LV/RV) volumes | Pre-treatment, 3 months, 6 months post-treatment | Volumes of LV and RV chamber - each derived from tracing the endocardial borders at end-diastole and end-systole in a cardiac MRI scan. |
| Change in myocardial strain | Pre-treatment, 3 months, 6 months post-treatment | Myocardial strain measures how much the heart muscle stretches or contracts during a heartbeat. Strain is measured on cardiac MRI images by tracking myocardial deformation using feature tracking techniques, which analyze changes in myocardial length or orientation between end-diastole and end-systole to calculate strain values. |
| Change in T1 Mapping | Pre-treatment, 3 months, 6 months post-treatment | By acquiring a series of images at different inversion times (Modified Look-Locker Inversion recovery sequence), the longitudinal relaxation time of myocardial tissue on a pixel-by-pixel basis to derive the T1 map. |
| Change in extracellular volume fraction (ECV) | Pre-treatment, 3 months, 6 months post-treatment | Extracellular volume fraction (ECV) is measured in cardiac MRI by first acquiring T1 maps of the heart before and after administering a gadolinium-based contrast agent, then using the change in T1 values of both the myocardium and blood pool-along with the patient's hematocrit-to calculate the proportion of the heart tissue made up of extracellular space. |
| Change in T2 mapping | Pre-treatment, 3 months, 6 months post-treatment | T2 maps are derived by acquiring images at multiple echo times using a T2-prepared sequence and analyzed. |
| Change in semi-quantitative perfusion | Pre-treatment, 3 months, 6 months post-treatment | Semi-quantitative perfusion analysis in cardiac MRI is used to assess myocardial blood flow by analyzing the dynamic passage of contrast agent through the heart muscle. The process involves acquiring first-pass contrast-enhanced images, defining myocardial and blood pool contours, segmenting the myocardium, and generating signal intensity curves to extract parameters such as upslope and time to peak-providing insight into regional perfusion |
| Change in late gadolinium enhancement | Pre-treatment, 3 months, 6 months post-treatment | Late gadolinium enhancement (LGE) in cardiac MRI is measured by acquiring inversion recovery images post-contrast, nulling normal myocardium, and quantifying enhancing regions using signal intensity thresholds relative to remote myocardium to assess myocardial scar or fibrosis. |
| Change Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score | Baseline to 12 months post-treatment (up to 14 months) | Using the abbreviated Kansas City Cardiomyopathy Questionnaire (KCCQ-12) quality of life will be measured. The KCCQ-12 is a heart failure-specific health status measure that provides scores for physical limitation, symptom frequency, quality of life, and social limitation. Scores range from 0 to 100, with higher scores indicating better health. Ranges like "very poor to poor" (0-24), "poor to fair" (25-49), "fair to good" (50-74), and "good to excellent" (75-100), can add further categorization. |
| Change in Functional Assessment of Cancer Therapy - Lung (FACT-L) Score | Baseline to 12 months post-treatment (up to 14 months) | The FACT-L Scale is a 36-item self-report instrument that measures multidimensional quality of life. It is scored on a 5-point Likert scale ranging from 0-4, with 0 = not at all and 4 = very much. Scores range from 0-144 where higher scores indicate greater quality of life. |
| Toxicity related to cancer | Baseline, mid-treatment, end of treatment, 3, 6,9, and 12 months post-treatment | Toxicity will be measured by number of adverse events |
Countries
United States
Contacts
CONTACTCancer Connect
PRINCIPAL_INVESTIGATORCarri Glide-Hurst, PhD, DABR, FAAPM
University of Wisconsin, Madison
Outcome results
None listed