Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation
NCT ID: NCT05010109
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2021-07-05
2026-02-23
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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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.
6 Minute Walk Functional Test
Participate in 6 MWT
Biospecimen Collection
Undergo blood and urine sample collection
Computed Tomography
Undergo SPECT/CT
Echocardiography
Undergo echocardiogram
Exercise Cardiac Stress Test
Undergo stress test
Questionnaire Administration
Complete questionnaires
Single Photon Emission Computed Tomography
Undergo SPECT/CT
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.
6 Minute Walk Functional Test
Participate in 6 MWT
Biospecimen Collection
Undergo blood and urine sample collection
Computed Tomography
Undergo SPECT/CT
Echocardiography
Undergo echocardiogram
Exercise Cardiac Stress Test
Undergo stress test
Questionnaire Administration
Complete questionnaires
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Interventions
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6 Minute Walk Functional Test
Participate in 6 MWT
Biospecimen Collection
Undergo blood and urine sample collection
Computed Tomography
Undergo SPECT/CT
Echocardiography
Undergo echocardiogram
Exercise Cardiac Stress Test
Undergo stress test
Questionnaire Administration
Complete questionnaires
Single Photon Emission Computed Tomography
Undergo SPECT/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Zhongxing Liao, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2021-02280
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-0071
Identifier Type: OTHER
Identifier Source: secondary_id
2021-0071
Identifier Type: -
Identifier Source: org_study_id
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