NCT05010109

Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation

Longitudinal Assessment of Cardiovascular Injury and Cardiac Fitness in LA-NSCLC Patients Receiving Model Based Personalized Chemoradiation - an Adaptive Cohort Registration Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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.

Conditions

• Locally Advanced Lung Non-Small Cell Carcinoma
• Stage III Lung Cancer AJCC v8
• Stage IIIA Lung Cancer AJCC v8
• Stage IIIB Lung Cancer AJCC v8
• Stage IIIC Lung Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	6 Minute Walk Functional Test	Participate in 6 MWT
PROCEDURE	Biospecimen Collection	Undergo blood and urine sample collection
PROCEDURE	Computed Tomography	Undergo SPECT/CT
PROCEDURE	Echocardiography	Undergo echocardiogram
PROCEDURE	Exercise Cardiac Stress Test	Undergo stress test
OTHER	Questionnaire Administration	Complete questionnaires
PROCEDURE	Single Photon Emission Computed Tomography	Undergo SPECT/CT

Timeline

• Start date: 2021-07-05
• Primary completion: 2027-02-02
• Completion: 2027-02-02
• First posted: 2021-08-18
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States