Assessing heart health in lung cancer patients receiving 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 is testing how personalized chemoradiation treatment for lung cancer affects heart health in patients and if adjusting the treatment can help reduce heart disease risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05010109 on ClinicalTrials.gov |
What this trial studies
This study evaluates cardiovascular injury and cardiac fitness in patients with locally advanced non-small cell lung cancer undergoing personalized chemoradiation. It aims to understand the risk of heart disease associated with treatment and whether this risk can be mitigated by tailoring therapy based on individual patient profiles. Participants will undergo various assessments, including imaging tests and functional walking tests, before, during, and after treatment. The study will follow patients for up to 10 years to monitor long-term cardiac health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a histologic diagnosis of locally advanced non-small cell lung cancer who are eligible for chemoradiation therapy.
Not a fit: Patients with previous thoracic radiation therapy or those with contraindications for protocol tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that protect heart health in lung cancer patients.
How similar studies have performed: Other studies have shown promising results in assessing cardiovascular risks in cancer patients, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Zhongxing Liao, MD — M.D. Anderson Cancer Center
- Study coordinator: Zhongxing Liao, MD
- Email: zliao@mdanderson.org
- Phone: 832-829-5312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.