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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 years
  • Procedures mentioned: CT scans, Blood draws, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at heart damage and heart fitness during personalized chemotherapy and radiation treatment for lung cancer. It focuses on non-small cell lung cancer that has spread nearby, but people with small cell lung cancer may also qualify. Researchers want to learn whether using each person's risks to guide treatment can help protect the heart.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have non-small cell or small cell lung cancer confirmed by a tissue test.
  • Have a plan for chest radiation given at the same time as chemotherapy and/or immunotherapy, which helps the immune system fight cancer. Other cancer medicines may also be given before or after.
  • Be at least 18 years old.
  • Have a Karnofsky score of at least 70, meaning you can care for yourself but may not be able to work or do normal activities.
  • Be willing and able to sign forms agreeing to join the study.
  • Be willing to do a 6-minute walking test.
  • Be willing to have the required heart biomarker test, which measures signs of heart health.

Who can't join

  • Cannot or do not want to give written agreement to join the study.
  • Had chest radiation before in an area that overlaps with the planned treatment area.
  • Are pregnant or breastfeeding.
  • Have kidney failure that needs dialysis, a treatment that filters the blood.
  • Do not want to do the required study tests.
  • Have a medical reason that makes any required study test unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

TX