Lung Cancer Clinical Trial
Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation
Summary
This study assesses cardiovascular injury and cardiac fitness in patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) receiving model based personalized chemoradiation. The goal of this study is to learn more about the risk of developing heart disease as a result of chemoradiation treatment for lung cancer. Researchers also want to learn if the risk can be reduced by using a patient's individual risk profile to guide cancer treatment and help protect the heart.
Full Description
PRIMARY OBJECTIVE:
I. To longitudinally assess cardiac injury (serum biomarkers, and grade >= 2 cardiac events), and overall cardiac fitness (6-minute-walk test) in locally advanced (LA)-non-small cell lung cancer (NSCLC) patients receiving chemoradiation.
OUTLINE:
Patients undergo single photon emission computed tomography (SPECT)/computed tomography (CT) with stress test and echocardiogram with strain before radiation therapy (RT), 6-8 weeks and 12 months after completion of RT. Patients also participate in 6 minute walk test (MWT) before RT, 2-3 and 6-7 weeks during RT, then 6-8 weeks, 4-6 months and 12 months after completion of RT. Patients undergo blood sample collection and complete questionnaires over 3-5 minutes before RT, 2-3, 4-5, 6-7 weeks after the initiation of RT, then at 3, 6, 12, and 24 months after completion of RT.
After completion of study treatment, patients are followed up annually for up to 10 years.
Eligibility Criteria
Inclusion Criteria:
Patient with histologic diagnosis of non-small cell lung cancer
The recommended treatment is thoracic radiation therapy combined with concurrent systemic therapy (chemotherapy and/or immunotherapy) with or without neoadjuvant and/or adjuvant systemic therapy (chemotherapy, immunotherapy, targeted therapy)
>= 18 years of age
Karnofsky performance status (KPS) >= 70
Willing and able to sign informed consents
Able and willing to perform 6minute walking test
Able and willing to preform required cardiac imaging examinations
Exclusion Criteria:
Unable or unwilling to give written informed consent
Previous history of RT to the thorax
Any contraindication for cardiac imaging
Pregnant or breast-feeding
Renal failure necessitating dialysis
Unable to perform protocol tests
Contraindication for any protocol tests
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There is 1 Location for this study
Houston Texas, 77030, United States More Info
Principal Investigator
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