HEARTS Trial for Thoracic Cancers

University of Wisconsin (UW)

Status and phase: Enrolling; Phase 2

Conditions: Other Cancers in the Thoracic Region; Esophageal Cancer Stage I-III; Non-Small Cell Lung Cancer (Stage III); Thymoma and Thymic Carcinoma Stage II-III; Esophagogastric Cancer Stage I-III

Treatments: Radiation: LINAC; Radiation: MRgART

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07132918

A533300 (Other Identifier)

Protocol Version 10/31/2025 (Other Identifier)

5R01HL153720-03 (U.S. NIH Grant/Contract)

SMPH/HUMAN ONCOLOGY/HUMAN ONCO (Other Identifier)

2025-0798

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 IIIA,IIIB, or IIIC non-operable non-small cell lung cancer
  • 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.

• Participants must have a definitive 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

MRgART radiation therapy

Experimental group

Description:

Participants randomized to this arm will receive magnetic resonance-guided adaptive radiation therapy (MRgART)

Treatment:

Radiation: MRgART

LINAC radiation therapy

Experimental group

Description:

Participants randomized to this arm will receive linear accelerator (LINAC) radiation therapy

Treatment:

Radiation: LINAC