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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering radiation that might better protect lymphocytes, which help fight infections. Researchers aim to determine if this approach can reduce the drop in lymphocytes in patients with non-small cell lung cancer (NSCLC) undergoing stereotactic body radiation therapy (SBRT), compared to standard radiation treatment. Participants will receive either SBRT with additional treatment planning dose optimization to protect blood-rich organs or SBRT with standard care planning. The trial is suitable for those diagnosed with NSCLC who are receiving SBRT and have tumors that cannot be surgically removed. As an unphased trial, this study offers patients the chance to contribute to innovative research that may improve future cancer treatments.

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.

What prior data suggests that this radiation planning method is safe for lymphocyte preservation?

Research has shown that stereotactic body radiation therapy (SBRT) is generally safe, but it can often decrease lymphocyte counts. Lymphocytes are crucial immune cells that help fight infections. Some studies have found that reduced lymphocyte levels can lead to worse outcomes for patients with certain cancers.

In this study, researchers are testing a new radiation treatment planning method. This approach aims to reduce lymphocyte damage compared to standard radiation techniques. While SBRT is usually well-tolerated, it carries a risk of lowering lymphocyte levels. The new planning method seeks to minimize this risk, potentially making the treatment safer for the immune system.

Research in other cancers, such as prostate cancer, supports the safety of SBRT. However, this study focuses on reducing the impact on lymphocytes during lung cancer treatment. If successful, this method could offer a safer option by better protecting immune cells. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how better planning in radiation therapy can help protect lymphocyte counts in lung cancer patients. Standard treatments like SBRT (Stereotactic Body Radiation Therapy) are used to target tumors with precision, but they can still affect lymphocytes, which are crucial for immune function. This trial's unique approach uses additional dose optimization criteria to potentially minimize the decrease in these important immune cells. By refining how radiation doses are planned and delivered, the trial aims to improve patient outcomes without compromising the effectiveness of the cancer treatment.

What evidence suggests that this trial's treatments could be effective for reducing lymphocyte decrease in NSCLC patients?

Research shows that stereotactic body radiation therapy (SBRT), a type of radiation treatment, can reduce lymphocytes, which are white blood cells that help fight infections. This reduction is linked to worse outcomes for lung cancer patients. In this trial, one group will receive SBRT with additional treatment planning dose optimization to minimize lymphocyte reduction. Studies have found that carefully planning the radiation to avoid areas with significant blood flow can protect these important cells. Specifically, reducing radiation to the heart and other key areas helps preserve more lymphocytes. This approach may improve survival rates by maintaining a stronger immune system while still effectively targeting the cancer. Another group in this trial will receive SBRT with standard care planning only, without additional dose optimization. ^{1 2 6 7 8}

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

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]

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 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. withpower.com withpower.com/trial/early-phase-1-1-2020-b0342

Radiation Planning for Lymphocytopenia Research shows that stereotactic body radiation therapy (SBRT) is effective for treating spinal metastases and prostate cancer, with improvements in treatment ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11617573/

Late radiation-related lymphopenia after prostate stereotactic ... In a patient cohort treated with SBRT for lung cancer, lymphopenia following SBRT was found to be associated with a poorer prognosis for ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405631625000879

Prediction of Grade 4 radiation-induced lymphopenia ... Radiation-induced lymphopenia (RIL) is a significant side effect associated with radiation therapy (RT) with important prognostic implications.

4. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2019.01488/full

Prognosis and Risk Factors of Radiation-Induced ... Lowering heart V5 and TBT when designing SBRT plans may spare circulating lymphocytes and have the potential to further improve survival outcomes.

5. thegreenjournal.com thegreenjournal.com/article/S0167-8140(23)09348-9/fulltext

Modeling frameworks for radiation induced lymphopenia The study also found that increasing the radiation dose rate was more effective at reducing lymphocyte depletion than reducing the number of ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/93/NCT04273893/Prot_SAP_001.pdf

A pilot randomized study of lymphocyte depletion and change in ... ... SBRT decrease in lymphocyte count and to determine whether additional steps in SBRT planning will deliver lower risk of post-SBRT decreases in lymphocyte count.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0939388916300046

Optimization of stereotactic body radiotherapy treatment ... The VMAT-MCO algorithm appears to be a valuable tool that provides high-quality SBRT plans with an efficient treatment planning time.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6748162/

Association Between Circulating Lymphocyte Populations ... Conclusions: Peripheral lymphopenia after SBRT might be an independent prognostic factor for poorer outcome in HCC patients. Post-treatment lymphocyte subsets, ...