Actively Recruiting
Longitudinal Assessment of Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation - an Adaptive Cohort Registration Study
Led by M.D. Anderson Cancer Center · Updated on 2026-03-11
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating cardiovascular injury and heart fitness in patients with locally advanced non-small cell lung cancer who are receiving model-based personalized chemoradiation. The study aims to understand the risk of heart disease caused by chemoradiation treatment and whether using a patient's individual risk profile can help reduce this risk. This is an interventional study focusing on heart health during cancer treatment. Participants receive chemoradiation and undergo several assessments including single photon emission computed tomography (SPECT)/computed tomography (CT) with stress tests, echocardiograms with strain, and 6-minute walk tests. These tests are done before radiation therapy, during treatment, and at multiple points up to 12 months after treatment. Blood samples are collected, and questionnaires are completed before treatment and over two years after treatment ends. The study includes two groups: one receiving standard care and the other receiving personalized treatment based on models. Throughout the study, participants complete heart fitness tests and biomarker assessments at regular intervals during and after treatment. Follow-up visits occur up to 10 years to monitor survival and long-term heart health. Researchers measure heart injury using biomarkers like hs-TnT levels and track cardiovascular events, overall cardiac fitness, and patient-reported outcomes. This extensive monitoring helps researchers understand the impact of chemoradiation on heart health over time.
CONDITIONS
Brief Title
Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with histologic diagnosis of non-small cell lung cancer, small cell lung cancer, or limited stage - small cell lung cancer (L-SCLC)
- Recommended treatment includes thoracic radiation therapy combined with concurrent systemic therapy (chemotherapy and/or immunotherapy) with or without neoadjuvant and/or adjuvant systemic therapy
- 18 years of age or older
- Karnofsky Performance Status (KPS) of 70 or higher
- Willing and able to sign informed consent forms
- Willing to perform the 6-minute walking test
- Willing to undergo required cardiac biomarker tests for primary endpoint assessment
You will not qualify if you...
- Unable or unwilling to provide written informed consent
- Previous radiation therapy to the chest overlapping with the current treatment area
- Pregnant or breastfeeding
- Renal failure requiring dialysis
- Unwilling to perform study protocol tests
- Contraindications for any protocol tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 7 weeks
Participants receive chemoradiation therapy during which cardiac fitness and injury are assessed through tests and questionnaires.
Visits before treatment and at 2-3 and 6-7 weeks during treatment for tests and questionnaires
Duration - Up to 12 months
Participants undergo follow-up testing to assess cardiac injury and fitness after completion of chemoradiation therapy.
Visits at 6-8 weeks and 12 months after treatment completion for imaging and functional tests; additional visits at 3, 4-6, 6, and 24 months for blood samples and questionnaires
Duration - Up to 10 years
Participants are followed annually to monitor overall survival and long-term cardiac health.
Annual follow-up visits
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Z
Zhongxing Liao, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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