This study determines how radiation therapy affects different ways of measuring the heart’s function and whether this changes depending on the dose of radiation the heart receives, or which parts of the heart are touched by the radiation, in patients with lung cancer that has not spread from where it first started (primary site) to other places in the body (non-metastatic). Information from this study may help researchers better understand how to reduce heart damage from radiation therapy and how to improve treatment of patients with non-metastatic lung cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04305613.
PRIMARY OBJECTIVES:
I. To quantify radiation therapy (RT)-related changes in circulating biomarkers of cardiovascular (CV) stress, inflammation and vascular dysfunction, and to define the associations between RT dose-volume measures and biomarkers.
II. To quantify RT-related changes in imaging-derived measures of CV function and perfusion, and to define the associations between RT dose-volume measures and CV function and perfusion.
III. To determine the prognostic value of biologic, imaging, and RT dose-volume measures as indicators of adverse CV outcomes, by defining the associations between early changes in these measures and CV outcomes.
SECONDARY OBJECTIVES:
I. To determine the associations between changes in CV biomarkers and quality of life (QOL) and activity measures.
II. To determine the associations between changes in measures of cardiac function and perfusion and QOL and activity measures.
III. To determine the associates between changes in RT dose volume measures and QOL and activity measures.
OUTLINE:
Patients undergo collection of blood, serum, and buffy coat samples at baseline, end of RT, 6 months, and 12 months, undergo positron emission tomography/computed tomography (PET/CT) scan at baseline and 6 months, and undergo echocardiogram at baseline, end of RT, 6 months, and 12 months. Patients also complete surveys at baseline, end of RT, 6, 12, and 24 months, and optionally at years 3, 4, and 5.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorBonnie Ky