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

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.

Study Overview

• Status: Recruiting
• Conditions: Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Locally Advanced Lung Non-Small Cell Carcinoma
• Intervention / Treatment: Procedure: Echocardiography; Other: Questionnaire Administration; Procedure: 6 Minute Walk Functional Test; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Exercise Cardiac Stress Test; Procedure: Single Photon Emission Computed Tomography

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhongxing Liao, MD; Phone Number: 832-829-5312; Email: zliao@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Principal Investigator: Zhongxing Liao
      • Contact: Zhongxing Liao; Phone Number: 832-829-5312; Email: zliao@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard Treatment Plan (Cohort One); Patients undergo SPECT/CT with stress test and echocardiogram with strain before RT, 6-8 weeks and 12 months after completion of RT. Patients also participate in 6 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.	Procedure: Echocardiography; Undergo echocardiogram; Other Names: ECHO_TEST; Other: Questionnaire Administration; Complete questionnaires; Procedure: 6 Minute Walk Functional Test; Participate in 6 MWT; Other Names: 6MWT; SIX MINUTE WALK; SIXMW1; Procedure: Biospecimen Collection; Undergo blood and urine sample collection; Procedure: Computed Tomography; Undergo SPECT/CT; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Procedure: Exercise Cardiac Stress Test; Undergo stress test; Other Names: ECST; Exercise Stress Test; Procedure: Single Photon Emission Computed Tomography; Undergo SPECT/CT; Other Names: Medical Imaging, Single Photon Emission Computed Tomography; Single Photon Emission Tomography; single-photon emission computed tomography; SPECT; SPECT imaging; SPECT SCAN; SPET; tomography, emission computed, single photon; Tomography, Emission-Computed, Single-Photon
Experimental: Model Based Personalized Treatment Plan (Cohort Two); Patients undergo SPECT/CT with stress test and echocardiogram with strain before RT, 6-8 weeks and 12 months after completion of RT. Patients also participate in 6 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.	Procedure: Echocardiography; Undergo echocardiogram; Other Names: ECHO_TEST; Other: Questionnaire Administration; Complete questionnaires; Procedure: 6 Minute Walk Functional Test; Participate in 6 MWT; Other Names: 6MWT; SIX MINUTE WALK; SIXMW1; Procedure: Biospecimen Collection; Undergo blood and urine sample collection; Procedure: Computed Tomography; Undergo SPECT/CT; Other Names: CT; CAT; CAT Scan; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Procedure: Exercise Cardiac Stress Test; Undergo stress test; Other Names: ECST; Exercise Stress Test; Procedure: Single Photon Emission Computed Tomography; Undergo SPECT/CT; Other Names: Medical Imaging, Single Photon Emission Computed Tomography; Single Photon Emission Tomography; single-photon emission computed tomography; SPECT; SPECT imaging; SPECT SCAN; SPET; tomography, emission computed, single photon; Tomography, Emission-Computed, Single-Photon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase in level of hs-TnT >= 5ng/L	Baseline up to end or chemoradiation (CRT)	up to 24 months
Incidence of grade >= 2 cardiovascular events	Defined by Common Terminology Criteria for Adverse Events version 5.0.	Within 12-month of completion of CRT]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		Up to 10 years
Overall cardiac fitness	Assessed using 6 minute walk test.	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	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	Up to 24 months after CRT

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Zhongxing Liao, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Physical Phenomena; Diagnostic Techniques, Respiratory System; Electromagnetic Phenomena; Magnetic Phenomena; Diagnostic Techniques, Cardiovascular; Electromagnetic Radiation; Radiation; Radiation, Ionizing; Elementary Particles; Light; Optical Phenomena; Radiation, Nonionizing; Heart Function Tests; Respiratory Function Tests; Ergometry; X-Rays; Photons; Exercise Test
• Other Study ID Numbers: 2021-0071 (Other Identifier: M D Anderson Cancer Center); NCI-2021-02280 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 1R01HL157273-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No