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Lymphocyte Depletion and Change in Lymphocyte Functionality

NCT04273893 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-12-10

Study results available
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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.

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.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Krishni Wijesooriya, PhD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2023-05-15
Completion
2025-06-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04273893 on ClinicalTrials.gov