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ACTIVE NOT RECRUITING

NCT04273893

Lymphocyte Depletion and Change in Lymphocyte Functionality

Sponsor: University of Virginia

View on ClinicalTrials.gov

Summary

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.

Official title: A Pilot Randomized Study of Lymphocyte Depletion & Change in Lymphocyte Functionality During Lung Stereotactic Body Radiation (SBRT) Therapy Treatment by Selectively Reducing Irradiation of Immune Rich Organs Compared to Standard of Care Control Group

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-02-12

Completion Date

2025-06-01

Last Updated

2024-12-10

Healthy Volunteers

Conditions

Lymphocyte Depletion

Interventions

RADIATION

SBRT with additional treatment planning dose optimization

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.

RADIATION

SBRT with standard of care planning only

Lung SBRT 50-60Gy in 5 fractions with standard of care planning (no additional dose optimization beyond SOC)

DIAGNOSTIC_TEST

Blood Draws

CBC w/ Diff and additional blood analysis for all participants in both groups. Blood draws will prior to treatment, end of treatment, 4 weeks after treatment, and 6 months after treatment.

Inclusion Criteria: 1. Willingness and ability to provide written informed consent and to comply with the study protocol. 2. Diagnosis of biopsy confirmed non-small cell lung cancer (NSCLC) with planned treatment with SBRT as definitive therapy OR imaging confirmed lung lesion for which SBRT is planned for primary lung cancer (when clinician determines biopsy is not indicated), Registration should occur within 5 business days (before or after) of planning CT. 3. Patients must decline surgery or tumor(s) must be considered to be medically inoperable 4. Location and size of tumor- Participants must have either: * peripherally located tumors (\> 2 cm in all directions from the proximal bronchial tree; see Figure 2 above) as defined by RTOG 0915, OR * centrally located tumors (tumor size ≤ 5 cm, tumors within or touching the zone of the proximal bronchial tree or adjacent to mediastinal or pericardial pleura) as defined by RTOG 0813. 5. Patients with recurrence of prior surgically treated lung cancers are eligible if no further surgery is planned and they otherwise meet the eligibility criteria. 6. Measurable disease on chest CT, PET CT, CT simulation at diagnosis ( must be within 8 weeks of SBRT). 7. Pre- radiation therapy total lymphocyte count \> 0.5k/μL on blood count drawn within 2 weeks prior to registration. 8. In the opinion of the treating clinician, patient is medically able to tolerate the study SBRT treatment of 50-60 Gy in 5 fractions. 9. ECOG performance status of 0-2. 10. Age ≥ 18 years. 11. If participant is a woman of childbearing potential (WOCBP), agreement to adhere to contraception requirements from the time of consent through completion of SBRT. Exclusion Criteria 1. Prior history of radiation therapy within 2 years of registration, however radiation therapy for skin cancer is allowed 2. Systemic anti-cancer therapy within the last year prior to registration or planned use during or within 6 months following SBRT. 3. Major surgery within the last 30 days before registration and/or planned before the completion of the 6 months post SBRT follow up timeframe. 4. Subject is a prisoner. 5. Subject is a pregnant woman. 6. Patient is not medically able to tolerate the study SBRT treatment of 50-60 Gy in 5 fractions or cannot comply with other aspects of the study including serial bloodwork. 7. Subject has HIV, AIDS, any type of hepatitis and/or any blood borne infectious disease for which the research lab cannot receive blood samples.

Locations (1)

University of Virginia

Charlottesville, Virginia, United States