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Radiation Therapy

SBRT with additional treatment planning dose optimization 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
Age ≥ 18 years
Patients must decline surgery or tumor(s) must be considered to be medically inoperable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 6 months sbrt according to ctcae version 5.0
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have chosen not to undergo surgery or my tumor cannot be removed surgically.
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My tumor is either more than 2 cm away from the central airways or is 5 cm or smaller and close to or touching the central airways or heart lining.
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I am able to get out of my bed or chair and move around.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Adverse Event Profile

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
~310

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
752 Previous Clinical Trials
1,239,603 Total Patients Enrolled
Krishni Wijesooriya, PhDPrincipal Investigator - University of Virginia
University of Virginia
Krishni Wijesorriya, PhDPrincipal InvestigatorUniversity of Virginia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity to become part of this clinical endeavor?

"This clinical trial is actively recruiting participants, as evidenced by the data hosted on clinicaltrials.gov that was first posted on December 2nd 2020 and most recently updated July 16th 2021."

Answered by AI

What is the upper cap for participants in this clinical experiment?

"Affirmative, the clinicaltrials.gov webpage reveals that this medical trial is presently looking for participants. It was initially posted on February 12th 2020 and most recently updated on July 16th 2021. The study requires 53 patients at a single site to be recruited."

Answered by AI
~10 spots leftby Mar 2025