HEARTS Trial for Thoracic Cancers

NCT ID: NCT07132918

Last Updated: 2025-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-08

Study Completion Date

2029-03-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MRgART radiation therapy

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

Group Type EXPERIMENTAL

MRgART

Intervention Type RADIATION

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.

LINAC radiation therapy

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

Group Type EXPERIMENTAL

LINAC

Intervention Type RADIATION

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

Interventions

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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.

Intervention Type RADIATION

LINAC

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carri Glide-Hurst, PhD, DABR, FAAPM

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin - Madison

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cancer Connect

Role: CONTACT

800-622-8922

Facility Contacts

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Cancer Connect

Role: primary

800-622-8922

Other Identifiers

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5R01HL153720-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A533300

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/HUMAN ONCOLOGY/HUMAN ONCO

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 10/31/2025

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0798

Identifier Type: -

Identifier Source: org_study_id

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