RecruitingInterventional

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

NCT ID: NCT05010109Sponsor: M.D. Anderson Cancer CenterLast updated: 2026-03-11

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.

Arms & interventions

Procedure6 Minute Walk Functional Test
Participate in 6 MWT
ProcedureBiospecimen Collection
Undergo blood and urine sample collection
ProcedureComputed Tomography
Undergo SPECT/CT
ProcedureEchocardiography
Undergo echocardiogram
ProcedureExercise Cardiac Stress Test
Undergo stress test
OtherQuestionnaire Administration
Complete questionnaires
ProcedureSingle Photon Emission Computed Tomography
Undergo SPECT/CT

Outcome measures

Primary

Increase 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]

Secondary

Overall cardiac fitness
Time frame: Up to 24 months after CRT
EuroQol 5 Dimension 5 Level: Patient reported outcomes
Time frame: Up to 24 months after CRT
MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes
Time frame: Up to 24 months after CRT
Overall survival
Time frame: Up to 10 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: 1. Patient with histologic diagnosis of non-small cell lung cancer, small cell lung cancer, or limited stage - small cell lung cancer (L-SCLC) 2. 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) 3. \>/= 18 years of age 4. KPS \>/= 70 5. Willing and able to sign informed consents 6. Willing to perform 6minute walking test 7. Willing to preform required cardiac biomarker test for primary end point assessment. Exclusion criteria: 1. Unable or unwilling to give written informed consent 2. Previous history of RT to the thorax overlapping with the current treatment field. 3. Pregnant or breast-feeding 4. Renal failure necessitating dialysis 5. Unwilling to perform protocol tests 6. Contraindication for any protocol tests

Study locations (1)

M D Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Zhongxing Liao · Contact

832-829-5312 zliao@mdanderson.org

Zhongxing Liao · Principal Investigator