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RecruitingPhase 2

HEARTS Trial for Thoracic Cancers

The cARdiac Radiation Therapy Sparing (HEARTS) for Thoracic Cancers

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Questionnaires, X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Participants will: * Receive radiation therapy * Undergo MRIs and bloodwork * Complete quality of life questionnaires"
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares radiation guided by MRI scans with standard radiation in people with cancer in the chest near the heart. It tests whether the two treatments affect the heart differently. Participants will get radiation, have MRI scans and blood tests, and answer questions about their quality of life.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18 when agreeing to join.
  • Have a radiation plan in which more than 10% of the heart would receive more than 25 Gy, a measure of radiation dose.
  • Have cancer confirmed by testing tissue or cells.
  • Have one of these cancers: non-small cell lung cancer that cannot be treated with surgery (stage IIB, IIIA, IIIB, IIIC, or IV); limited-stage small cell lung cancer treated once daily; or cancer of the food pipe or where it meets the stomach (stage I–III, N0–2).
  • Stage II or III cancer of the thymus gland, or another chest cancer such as lymphoma or sarcoma, may also qualify if other study rules are met.
  • Have at least 15 daily radiation treatments planned, usually with 1.8 to 4 Gy per treatment.

Who can't join

  • Have cancer that has clearly spread to distant areas, with an expected lifespan of less than 12 months.
  • Have had radiation to the chest that greatly overlaps the heart area.
  • Have a condition or other reason that makes MRI unsafe or unsuitable.
  • Have severe heart disease rated class III or IV by the New York Heart Association, meaning symptoms greatly limit activity or occur at rest.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

WI