Radiation Planning for Lymphocytopenia

Overseen By Song Wood

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

Must not be taking: Systemic anti-cancer therapy

Disqualifiers: Prior radiation, Major surgery, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

55 Participants Needed

What You Need to Know Before You Apply

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude participants who have had systemic anti-cancer therapy within the last year or plan to use it during or within 6 months after the trial.

Is stereotactic body radiation therapy (SBRT) generally safe for humans?

Research on SBRT for prostate cancer shows that it can be safe when strict dose limits are followed, but higher doses may lead to more side effects. ^{1 2 3 4 5}

How does the treatment SBRT with dose optimization differ from other treatments for lymphocytopenia?

This treatment is unique because it involves SBRT (Stereotactic Body Radiation Therapy), which is a highly focused form of radiation therapy, combined with additional dose optimization planning to potentially improve treatment outcomes. This approach is different from standard care as it aims to enhance the precision and effectiveness of radiation delivery, potentially reducing side effects and improving the sparing of healthy tissues. ^{2 6 7 8 9}

What data supports the effectiveness of this treatment?

Research shows that stereotactic body radiation therapy (SBRT) is effective for treating spinal metastases and prostate cancer, with improvements in treatment planning and delivery efficiency. This suggests that SBRT, with optimized planning, could be beneficial for other conditions like lymphocytopenia. ^{2 3 6 10 11}

Who Is on the Research Team?

Krishni Wijesooriya, PhD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

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

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

Subject is a pregnant woman

Subject is a prisoner

I have not had radiation therapy in the last 2 years, except for skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Lung SBRT 50-60Gy in 5 fractions with either standard of care planning or additional dose optimization to minimize lymphocyte depletion

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including lymphocyte count measurements

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• SBRT with additional treatment planning dose optimization
• SBRT with standard of care planning only

Trial Overview 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.

How Is the Trial Designed?

Group I: SBRT Additional treatment planning dose optimization Experimental Treatment 2 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 only Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Published Research Related to This Trial

Stereotactic body radiation therapy (SBRT) resulted in significantly lower post-treatment PSA levels compared to intensity-modulated radiation therapy (IMRT) at 2 and 3 years, indicating better efficacy in controlling prostate cancer.

Both SBRT and IMRT showed similar overall survival rates after 5 years, but SBRT offers advantages such as lower cost and easier application, making it a suitable alternative for treating localized prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy versus conventional intensity-modulated radiation therapy for the treatment of prostate cancer]. Gao, QN.[2022]

In a prospective phase II trial involving 110 patients aged 70 and older with localized prostate cancer, stereotactic body radiotherapy (SBRT) demonstrated a severe toxicity rate of less than 5%, confirming its safety for this patient population.

The SBRT regimen resulted in a biochemical progression-free survival (bPFS) rate of 90% over a median follow-up of 36 months, indicating its efficacy in treating localized prostate cancer without negatively impacting patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. Nguyen, P., Harzée, L., Retif, P., et al.[2022]

In a study of 41 hormone-naïve intermediate-risk prostate cancer patients treated with hypofractionated SBRT, the treatment resulted in a significant decrease in PSA levels from an average of 7.67 ng/mL to 0.64 ng/mL at a median follow-up of 21 months, indicating effective early clinical outcomes.

No severe toxicities (Grade 3 or 4) were observed, and while there was a temporary decline in urinary and bowel quality of life scores post-treatment, they returned to baseline levels, suggesting that SBRT is a safe option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiation therapy as monotherapy for intermediate-risk prostate cancer. Ju, AW., Wang, H., Oermann, EK., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Generalizable class solutions for treatment planning of spinal stereotactic body radiation therapy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility-guided automated planning for stereotactic treatments of prostate cancer. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A treatment planning study comparing IMRT techniques and cyber knife for stereotactic body radiotherapy of low-risk prostate carcinoma. [2020]

4. China pubmed.ncbi.nlm.nih.gov

[Stereotactic body radiation therapy versus conventional intensity-modulated radiation therapy for the treatment of prostate cancer]. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Outcomes of Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Patients with Lymph Node Metastases from Gynecological Cancers. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Prospective validation of stringent dose constraints for prostatic stereotactic radiation monotherapy: results of a single-arm phase II toxicity-oriented trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Increased toxicities associated with dose escalation of stereotactic body radiation therapy in prostate cancer: results from a phase I/II study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Hypofractionated stereotactic body radiation therapy as monotherapy for intermediate-risk prostate cancer. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Significant changes in macrophage and CD8 T cell densities in primary prostate tumors 2 weeks after SBRT. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized Automation of Treatment Planning for Linac-Based Stereotactic Body Radiotherapy of Spine Cancer. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Dose-Escalated Stereotactic Body Radiation Therapy for Prostate Cancer: Quality-of-Life Comparison of Two Prospective Trials. [2022]