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Recruiting NCT07132918

HEARTS Trial for Thoracic Cancers

Phase II Interventional Non-Small Cell Lung Cancer (Stage III) Esophageal Cancer Stage I-III Esophagogastric Cancer Stage I-III Thymoma and Thymic Carcinoma Stage II-III

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRgART, LINAC.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer (Stage III), Esophageal Cancer Stage I-III, Esophagogastric Cancer Stage I-III, Thymoma and Thymic Carcinoma Stage II-III. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The cARdiac Radiation Therapy Sparing (HEARTS) for Thoracic Cancers

Overview

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

  • Radiation MRgART
    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.
  • Radiation LINAC
    Daily 3D x-ray scans will be obtained for radiation delivery to confirm tumor and organ at risk placement.

Primary outcome measures

  • Change in left ventricular ejection fraction (LVEF) [Time frame: Pre-treatment, 3 months post-treatment, 6 months post-treatment]
Secondary outcome measures (11)
  • Change in right ventricular function (RVEF) [Time frame: Pre-treatment, 3 months, 6 months post-treatment]
  • Change in left and right ventricular (LV/RV) volumes [Time frame: Pre-treatment, 3 months, 6 months post-treatment]
  • Change in myocardial strain [Time frame: Pre-treatment, 3 months, 6 months post-treatment]
  • Change in T1 Mapping [Time frame: Pre-treatment, 3 months, 6 months post-treatment]
  • Change in extracellular volume fraction (ECV) [Time frame: Pre-treatment, 3 months, 6 months post-treatment]
  • Change in T2 mapping [Time frame: Pre-treatment, 3 months, 6 months post-treatment]
  • Change in semi-quantitative perfusion [Time frame: Pre-treatment, 3 months, 6 months post-treatment]
  • Change in late gadolinium enhancement [Time frame: Pre-treatment, 3 months, 6 months post-treatment]
  • Change Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score [Time frame: Baseline to 12 months post-treatment (up to 14 months)]
  • Change in Functional Assessment of Cancer Therapy - Lung (FACT-L) Score [Time frame: Baseline to 12 months post-treatment (up to 14 months)]
  • Toxicity related to cancer [Time frame: Baseline, mid-treatment, end of treatment, 3, 6,9, and 12 months post-treatment]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Wisconsin - Madison — Madison

Identifiers

NCT: NCT07132918 · 2025-0798 · 5R01HL153720-03 · A533300 · SMPH/HUMAN ONCOLOGY/HUMAN ONCO · Protocol Version 1/20/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗