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
3 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2021
CompletedStudy Start
First participant enrolled
July 5, 2021
CompletedFirst Posted
Study publicly available on registry
August 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 2, 2027
March 11, 2026
March 1, 2026
5.6 years
April 12, 2021
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Overall cardiac fitness
Up to 24 months after CRT
EuroQol 5 Dimension 5 Level: Patient reported outcomes
Up to 24 months after CRT
MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes
Up to 24 months after CRT
Overall survival
Up to 10 years
Study Arms (2)
Standard Treatment Plan (Cohort One)
EXPERIMENTALPatients 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)
EXPERIMENTALPatients 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.
Interventions
Participate in 6 MWT
Undergo blood and urine sample collection
Undergo SPECT/CT
Undergo echocardiogram
Undergo stress test
Complete questionnaires
Undergo SPECT/CT
Eligibility Criteria
You may qualify if:
- Patient with histologic diagnosis of non-small cell lung cancer, small cell lung cancer, or limited stage - small cell lung cancer (L-SCLC)
- 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
- KPS \>/= 70
- Willing and able to sign informed consents
- Willing to perform 6minute walking test
- Willing to preform required cardiac biomarker test for primary end point assessment.
You may not qualify if:
- Unable or unwilling to give written informed consent
- Previous history of RT to the thorax overlapping with the current treatment field.
- Pregnant or breast-feeding
- Renal failure necessitating dialysis
- Unwilling to perform protocol tests
- Contraindication for any protocol tests
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhongxing Liao, MD
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2021
First Posted
August 18, 2021
Study Start
July 5, 2021
Primary Completion (Estimated)
February 2, 2027
Study Completion (Estimated)
February 2, 2027
Last Updated
March 11, 2026
Record last verified: 2026-03