Overview
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.
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
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