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

Phase 1

Recruiting

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

• Registration Number: NCT05010109
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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 locally advanced (LA)-non-small cell lung cancer (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 Timeline

• Study First Submitted: 2021-04-12
• Study Start: 2021-07-05
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-18
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26
• Primary Completion: 2026-02-23
• Study Completion: 2026-02-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient with histologic diagnosis of non-small cell lung cancer
• 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)
• >= 18 years of age
• Karnofsky performance status (KPS) >= 70
• Willing and able to sign informed consents
• Able and willing to perform 6minute walking test
• Able and willing to preform required cardiac imaging examinations

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Exclusion Criteria

• Unable or unwilling to give written informed consent
• Previous history of RT to the thorax
• Any contraindication for cardiac imaging
• Pregnant or breast-feeding
• Renal failure necessitating dialysis
• Unable to perform protocol tests
• Contraindication for any protocol tests

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Standard Treatment Plan (Cohort One)	6 Minute Walk Functional Test	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.
Standard Treatment Plan (Cohort One)	Computed Tomography	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.
Standard Treatment Plan (Cohort One)	Biospecimen Collection	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.
Standard Treatment Plan (Cohort One)	Questionnaire Administration	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.
Standard Treatment Plan (Cohort One)	Echocardiography	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.
Standard Treatment Plan (Cohort One)	Exercise Cardiac Stress Test	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.
Model Based Personalized Treatment Plan (Cohort Two)	Biospecimen Collection	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.
Model Based Personalized Treatment Plan (Cohort Two)	Computed Tomography	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.
Model Based Personalized Treatment Plan (Cohort Two)	Echocardiography	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.
Model Based Personalized Treatment Plan (Cohort Two)	Questionnaire Administration	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.
Standard Treatment Plan (Cohort One)	Single Photon Emission Computed Tomography	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.
Model Based Personalized Treatment Plan (Cohort Two)	6 Minute Walk Functional Test	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.
Model Based Personalized Treatment Plan (Cohort Two)	Exercise Cardiac Stress Test	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.
Model Based Personalized Treatment Plan (Cohort Two)	Single Photon Emission Computed Tomography	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall survival	Up to 10 years
MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes	Up to 24 months after CRT	Score Range 0-10 (0) No symptom and (10) worst symptoms
Overall cardiac fitness	Up to 24 months after CRT	Assessed using 6 minute walk test.
EuroQol 5 Dimension 5 Level: Patient reported outcomes	Up to 24 months after CRT	Score Range 0-100 (0) Worst health and (100) best health Level 1- No complaints Level 5- Worst

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States