Trial Summary
What is the purpose of this trial?Lymphocytes are a type of white blood cell (WBC) responsible for adaptive immunity. Thoracic tumors are adjacent to many blood/immune rich organs including the great vessels, heart, thoracic-spine, and lymph-node-stations. During radiation treatment the impact to lymphocytes can be significant. This may cause a decrease in the amount of lymphocytes. A researcher at UVA has created a system to predict and reduce the immune cell reduction following lung SBRT treatments beyond standard of care. The predicted decrease in lymphocytes will be compared to the actual decrease in lymphocytes found in peripheral blood.
Researchers have found a way to give radiation that they think will result in a smaller decrease in lymphocytes after radiation. There will be two groups in this study, about half of the participants will have their radiation designed to decrease radiation to organs with a lot of blood and the other half will receive standard radiation therapy.
Participants are being asked to take part in this study because the participants have been diagnosed with NSCLC and will be receiving a type of radiation therapy called stereotactic body radiation therapy (SBRT) where high doses of radiation will be delivered to the tumor, while minimizing damage to healthy surrounding tissues.
Eligibility Criteria
This trial is for adults over 18 with non-small cell lung cancer (NSCLC) who are about to receive SBRT radiation therapy. They must have a certain type of tumor, be medically unable to have surgery or decline it, and have an adequate level of lymphocytes in their blood. Participants need to be able to consent and follow the study protocol.Inclusion Criteria
Willingness and ability to provide written informed consent and to comply with the study protocol
Pre-radiation therapy total lymphocyte count > 0.5k/μL on blood count drawn within 2 weeks prior to registration
I am 18 years old or older.
+8 more
Exclusion Criteria
Subject is a pregnant woman
Subject is a prisoner
I have not had radiation therapy in the last 2 years, except for skin cancer.
+4 more
Participant Groups
The study tests whether a new radiation treatment planning system can reduce the decrease in white blood cells called lymphocytes after SBRT compared to standard care. Patients will either get this optimized radiation or the usual treatment, decided randomly.
2Treatment groups
Experimental Treatment
Active Control
Group I: SBRT Additional treatment planning dose optimizationExperimental Treatment2 Interventions
Lung SBRT 50-60Gy in 5 fractions with standard of care planning and additional treatment planning dose optimization criteria to minimize decrease in lymphocyte count beyond dosimetric criteria from RTOG 0915/0813 SBRT trials.
Group II: SBRT with standard of care planning onlyActive Control2 Interventions
Lung SBRT 50-60Gy in 5 fractions with standard of care planning (no additional dose optimization beyond SOC)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of VirginiaCharlottesville, VA
Loading ...
Who Is Running the Clinical Trial?
University of VirginiaLead Sponsor