Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT04183218
Brief 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.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the 12-month cardiac event rate after radiation or chemo-radiation for the treatment of lung or esophageal cancer.
EXPLORATORY OBJECTIVES:
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.
OUTLINE:
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.
Study:
NCT04183218
Study Brief:
Protocol Section:
NCT04183218