RecruitingPhase 2NCT07132918

HEARTS Trial for Thoracic Cancers

The cARdiac Radiation Therapy Sparing (HEARTS) for Thoracic Cancers


Sponsor

University of Wisconsin, Madison

Enrollment

60 participants

Start Date

Oct 8, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria4

  • 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.

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.


Locations(1)

University of Wisconsin - Madison

Madison, Wisconsin, United States

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NCT07132918


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