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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curative Radiotherapy | Radiation | Radiation dose of 45 Gy or higher | ||
| Immunotherapy | Drug | checkpoint inhibitor per PI discretion |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cardiopulmonary toxicities | To determine clinical cardiopulmonary toxicities from standard RT and immunotherapy per CTCAEv5.0 | 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| subclinical/asymptomatic cardiopulmonary events | Asymptomatic cardiopulmonary events determined per abnormal lab values such as troponin and physiological testing | 25 months |
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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.
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:
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A total of 125 patients (MU: 25 patients, UR: 50 patients, Rutgers: 50 patients) who are 18 year of age or older, diagnosed with locally advanced lung cancer (defined as above) will be accrued in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hilary Elom, MD | Contact | 318-816-3582 | hebcq@health.missouri.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bo Lu, MD | Chair, Department of Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri - Ellis Fischel Cancer Center | Recruiting | Columbia | Missouri | 65212 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Plasma & PBMC samples will be collected as per protocol required. Samples will be analyzed per protocol.
| Rutgers Cancer Institute of New Jersey | Not yet recruiting | New Brunswick | New Jersey | 08901 | United States |
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| University of Rochester Medical Center | Not yet recruiting | Rochester | New York | 14642 | United States |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |