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.
PRIMARY OBJECTIVE: I.To longitudinally assess cardiac injury (serum biomarkers, and grade \>=2 cardiac events), and overall cardiac fitness (6-minute-walk test) in LA-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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
Participate in 6 MWT
Undergo blood and urine sample collection
Undergo SPECT/CT
Undergo echocardiogram
Undergo stress test
Complete questionnaires
Undergo SPECT/CT
M D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGIncrease in level of hs-TnT >= 5ng/L
Baseline up to end or chemoradiation (CRT)
Time frame: up to 24 months
Incidence of grade >= 2 cardiovascular events
Defined by Common Terminology Criteria for Adverse Events version 5.0.
Time frame: Within 12-month of completion of CRT]
Overall cardiac fitness
Assessed using 6 minute walk test.
Time frame: Up to 24 months after CRT
EuroQol 5 Dimension 5 Level: Patient reported outcomes
Score Range 0-100 (0) Worst health and (100) best health Level 1- No complaints Level 5- Worst
Time frame: Up to 24 months after CRT
MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes
Score Range 0-10 (0) No symptom and (10) worst symptoms
Time frame: Up to 24 months after CRT
Overall survival
Time frame: Up to 10 years
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