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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05010109
Status
Recruiting
Apply to this trial

Conditions

  • Locally Advanced Lung Non-Small Cell Carcinoma
  • Stage III Lung Cancer AJCC v8
  • Stage IIIA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IIIC Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 6 Minute Walk Functional Test — PROCEDURE
    Participate in 6 MWT
  • Biospecimen Collection — PROCEDURE
    Undergo blood and urine sample collection
  • Computed Tomography — PROCEDURE
    Undergo SPECT/CT
  • Echocardiography — PROCEDURE
    Undergo echocardiogram
  • Exercise Cardiac Stress Test — PROCEDURE
    Undergo stress test
  • Questionnaire Administration — OTHER
    Complete questionnaires
  • Single Photon Emission Computed Tomography — PROCEDURE
    Undergo SPECT/CT

Study Details

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.

Key Dates

Start date
Jul 5, 2021
Status verified
Mar 2026
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • 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.
  • 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.

Primary Outcome Measure

Increase in level of hs-TnT >= 5ng/L [ Time Frame: up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Zhongxing Liao
[email protected]
832-829-5312
Zhongxing Liao (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

Related Studies