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Radiation Therapy

Radiation Planning for Lymphocytopenia

N/A
Waitlist Available
Led By Krishni Wijesooriya, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 6 months sbrt according to ctcae version 5.0
Awards & highlights
No Placebo-Only Group

Summary

This trial will help researchers learn more about how to give radiation in a way that results in a smaller decrease in lymphocytes.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include typical reactions from radiation therapy such as fatigue, skin irritation at the treated site, and possible changes in blood counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 6 months sbrt according to ctcae version 5.0
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through 6 months sbrt according to ctcae version 5.0 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the prediction accuracy of the algorithm for the lymphocyte depletion post RT for the treatment in 50 evaluable participants with NSCLC
Impact of Lymphocyte-Sparing SBRT Planning Objectives on Post-SBRT Lymphocyte Count
Secondary study objectives
Adverse Event Profile

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Draws
2013
Completed Phase 2
~320

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,649 Total Patients Enrolled
Krishni Wijesooriya, PhDPrincipal Investigator - University of Virginia
University of Virginia
Krishni Wijesorriya, PhDPrincipal InvestigatorUniversity of Virginia
~9 spots leftby Nov 2025
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