Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Curative Radiotherapy, Immunotherapy.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multi-Center Pilot Biomarker Study With Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
Overview
The overall purpose of this study is to evaluate cardiopulmonary toxicity in patients with lung cancer (NSCLC or SCLC) undergoing combined thoracic radiotherapy ± chemotherapy and immunotherapy through timed monitoring and blood sample collection and to identify correlative biomarkers for predicting cardiopulmonary adverse events.
Detailed description
This aims to collect observational data that describe clinical (primary endpoint) and subclinical (secondary endpoint) cardiopulmonary toxicities from combined thoracic radiotherapy and immunotherapy up to 25 months after thoracic radiotherapy and 12 months after consolidation immunotherapy among patients with locally advanced lung cancer.
Interventions
- Radiation Curative Radiotherapy
Radiation dose of 45 Gy or higher - Drug Immunotherapy
checkpoint inhibitor per PI discretion
Primary outcome measures
- Clinical cardiopulmonary toxicities [Time frame: 25 months]
Secondary outcome measures (1)
- subclinical/asymptomatic cardiopulmonary events [Time frame: 25 months]
Eligibility criteria
Inclusion criteria
- Patient older than 18 years age
- Diagnosis of locally advanced lung cancer (NSCLC or SCLC) with planned curative radiotherapy (45Gy and above) and planned consolidation immunotherapy.
- Patients who are not receiving concurrent chemotherapy and radiotherapy are eligible.
- Patients on a clinical trial that includes thoracic radiotherapy and immunotherapy are eligible and may be co-enrolled to this study.
- ECOG performance status of 0-2
- Life expectancy of 6 months or longer
- Patient able to provide a written informed consent prior to study entry
Exclusion criteria
- Prior thoracic radiotherapy to chest.
- Patients are excluded if they are not candidates for curative thoracic radiotherapy or immunotherapy.
- Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 3 centers
- University of Missouri - Ellis Fischel Cancer Center — Columbia
- Rutgers Cancer Institute of New Jersey — New Brunswick
- University of Rochester Medical Center — Rochester
Identifiers
NCT: NCT06410300 · 2093626