CompletedNot Applicable

Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes

United States24 participantsStarted 2019-09-23

Plain-language summary

This trial studies cardiac changes after radiation or chemo-radiation for the treatment of lung or esophageal cancer that has not spread to other places in the body (non-metastatic) or has not come back (non-recurrent). Continuous cardiac monitoring with an implanted device may help to identify cardiac changes that would remain unnoticed, and facilitate the treatment of these early cardiac changes as part of standard care.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \>= 18 years * Planned standard of care curative thoracic RT or CRT with anticipated heart V40 \> 20 cc (At least 20 cc of the heart should receive a dose of 40 gray \[Gy\] or higher) * Able to follow-up at all specified standard of care time-points * Patients can receive treatment as part of the standard of care or in a different study * Receiving radiation treatment to an area close to the heart, for example gastroesophageal junction cancer, hilar lung cancer, or mainstem bronchus lung cancer * Any type of systemic therapy or surgery before during or after radiation is acceptable * Prior radiation to other areas is acceptable * Planned radiation doses equal or higher than 40 Gy Exclusion Criteria: * Metastatic disease * Recurrent disease * Patient receiving radiation prescription doses lower than 40 Gy * No prior radiation that included any part of the heart is acceptable * No thoracic re-irradiation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Participants With a Cardiac Event at 12 Months

Timeframe: Up to 12 months

Trial details

NCT IDNCT04183218

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-06

Results submitted2026-01-26

View on ClinicalTrials.gov More Clinical Stage 0 Esophageal Adenocarcinoma AJCC v8 trials