Characterizing Chemo-Radiotherapy Treatment-Related Cardiac Changes in Non-metastatic, Non-recurrent Lung and Esophageal Cancer Patients
- 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
- 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
I. To determine the 12-month cardiac event rate after radiation or chemo-radiation for the treatment of lung or esophageal cancer.
I. Define the spectrum of cardiac toxicity among chemoradiotherapy (CRT) patients at highest risk of cardiac toxicity.
II. Establish the timeline of cardiac toxicity development and identify early predictive findings of permanent damage.
III. Characterize the areas of the heart at highest risk for persistent cardiac damage.
IV. Identify a dose response threshold for radiotherapy (RT) damage in different areas of the heart.
V. Improve survival by alerting the cardiology team of the need for life-saving standard of care interventions.
VI. Describe medical interventions employed for the cardiac events identified in the study.
Patients receive cardiac monitor implants then undergo standard of care RT or CRT at the discretion of the treating physician. Patients also undergo blood sample collection at baseline, 4 weeks, 3, 9, and 12 months.
After completion of study treatment, patients are followed up at 4 weeks, 3, 9 and 12 months post RT.
Trial Phase Phase NA
Trial Type Prevention
Mayo Clinic in Arizona
Carlos Enrique Vargas
- Primary ID MC1723
- Secondary IDs NCI-2019-07938
- Clinicaltrials.gov ID NCT04183218