Lymphocyte Depletion and Change in Lymphocyte Functionality

NCT04273893 | Active Not Recruiting Results DMC

• 2 other identifiers: 217185R01CA234281-03
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lymphocyte Depletion and Change; SBRT; NSCLC; Lung Cancer; radiation therapy; non small cell; Stereotactic body radiation therapy; Treatment related lymphopenia

Outcome Measures

Primary Outcomes (2)

• Impact of Lymphocyte-Sparing SBRT Planning Objectives on Post-SBRT Lymphocyte Count

  Mean percentage difference of measured absolute lymphocyte counts between the baseline and at each time points for the two separate arms

  Baseline to End of SBRT (up to 12 days), 4 weeks after SBRT (up to 1.5 months) and 6 months after SBRT (up to 10 months)

• Determine if an Algorithm Can Predict the Magnitude of Post SBRT Lymphocyte Depletion Prospectively for Participants With NSCLC

  Median of the difference between predicted value and observed measurement of lymphocyte absolute counts.

  Baseline to End of SBRT (up to 12 days), 4 weeks after SBRT (up to 1.5 months) and 6 months after SBRT (up to 10 months)

Study Arms (2)

SBRT Additional treatment planning dose optimization

EXPERIMENTAL

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 additional treatment planning dose optimization; Diagnostic Test: Blood Draws

SBRT with standard of care planning only

ACTIVE COMPARATOR

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

Radiation: SBRT with standard of care planning only; Diagnostic Test: Blood Draws

Interventions

SBRT with additional treatment planning dose optimization RADIATION

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.

SBRT Additional treatment planning dose optimization

SBRT with standard of care planning only RADIATION

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

SBRT with standard of care planning only

Blood Draws DIAGNOSTIC_TEST

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.

SBRT Additional treatment planning dose optimization; SBRT with standard of care planning only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness and ability to provide written informed consent and to comply with the study protocol.
• Diagnosis of biopsy confirmed non-small cell lung cancer (NSCLC) with planned treatment with SBRT as definitive therapy OR imaging confirmed lung lesion for which SBRT is planned for primary lung cancer (when clinician determines biopsy is not indicated), Registration should occur within 5 business days (before or after) of planning CT.
• Patients must decline surgery or tumor(s) must be considered to be medically inoperable
• Location and size of tumor- Participants must have either:
• peripherally located tumors (\> 2 cm in all directions from the proximal bronchial tree; see Figure 2 above) as defined by RTOG 0915, OR
• centrally located tumors (tumor size ≤ 5 cm, tumors within or touching the zone of the proximal bronchial tree or adjacent to mediastinal or pericardial pleura) as defined by RTOG 0813.
• Patients with recurrence of prior surgically treated lung cancers are eligible if no further surgery is planned and they otherwise meet the eligibility criteria.
• Measurable disease on chest CT, PET CT, CT simulation at diagnosis ( must be within 8 weeks of SBRT).
• Pre- radiation therapy total lymphocyte count \> 0.5k/μL on blood count drawn within 2 weeks prior to registration.
• In the opinion of the treating clinician, patient is medically able to tolerate the study SBRT treatment of 50-60 Gy in 5 fractions.
• ECOG performance status of 0-2.
• Age ≥ 18 years.
• If participant is a woman of childbearing potential (WOCBP), agreement to adhere to contraception requirements from the time of consent through completion of SBRT.

You may not qualify if:

• Prior history of radiation therapy within 2 years of registration, however radiation therapy for skin cancer is allowed
• Systemic anti-cancer therapy within the last year prior to registration or planned use during or within 6 months following SBRT.
• Major surgery within the last 30 days before registration and/or planned before the completion of the 6 months post SBRT follow up timeframe.
• Subject is a prisoner.
• Subject is a pregnant woman.
• Patient is not medically able to tolerate the study SBRT treatment of 50-60 Gy in 5 fractions or cannot comply with other aspects of the study including serial bloodwork.
• Subject has HIV, AIDS, any type of hepatitis and/or any blood borne infectious disease for which the research lab cannot receive blood samples.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Wijesooriya K, Nguyen C, Conaway MR, Read PW, Romano K, Lum LG, Thakur A, Lain DW, McLaughlin CM, Luminais CK, Wood S, Williams G, Chen J, Walker B, Sprouts D, Muller D, Ward K, Dutta S, Sanders J, Cousins D, Asare E, Nesbit E, Chavis YC, Walker KV, Janowski E, Showalter T, Larner JM. First Measurement: Proactive Immune Cell Sparing in Radiation Therapy. medRxiv [Preprint]. 2025 Jan 6:2025.01.05.25320011. doi: 10.1101/2025.01.05.25320011.

  PMID: 39830271 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiosurgery; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures

Results Point of Contact

• Title: UVA Radiation Oncology Clinical Research Coordinator
• Organization: University of Virginia

UVARADONCClinicalTrials@uvahealth.org

434-243-0008

Study Officials

• Krishni Wijesooriya, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, clinical research staff, and treating clinicians will be aware of arm assignment. The labels on research blood will not include the treatment arm on which the participant is assigned and this information will not be provided to lab investigators and staff.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiation Oncology - Medical Physics

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 18, 2020
• Study Start: February 12, 2020
• Primary Completion: May 15, 2023
• Study Completion: June 1, 2025
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)