Purpose

The purpose of this study is to see whether designing radiation to spare the vertebral bone marrow can limit the rates of lymphopenia during standard of care chemoradiation therapy and in the time to count recovery in the ensuing weeks. Secondary endpoints will examine whether this leads to improved disease control whether this is predictive of improved clinical outcomes such as rates of local recurrence (LR), metastasis free survival (MFS), overall survival (OS), and progression free survival (PFS) which will be followed prospectively up to 5 years.

Category

IRB Number
20210892HU
NCT Number
NCT05248256
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Principal Investigator
Christien Kluwe

Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu

Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu

Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu

Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
18 and up
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    • Patients with AJCC 8 T1-T4, N1-N3, M0 stage IIB, IIIA-IIIC NSCLC
    • Patients with oligometastatic disease stage IV, M1 disease, in which concurrent chemoradiotherapy to the thorax is planned with or without adjuvant immunotherapy
    • CBC/CMP within these limits
      • Eastern Cooperative Oncology Group (ECOG) 0-2
      • Absolute lymphocyte count>0.8K/μ
      • Hemoglobin>8 g/dL AST/ALT <2.5 times of ULN

Exclusion Criteria

    • History of thoracic irradiation
    • History of palliative radiation for the current malignancy under consideration
    • Patients not being treated with a curative approach to the chest
    • History of bone marrow disease and or leukemia
    • History of prior cytotoxic chemotherapy for a disease other than for the current malignancy
    • Polymetastatic disease, defined here as ≥3 or more extrathoracic metastases
    • Administration of concurrent immunotherapy during radiation therapy, either as part of another clinical trial or otherwise

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Condition
  • Lung Cancer

Arm Groups

ArmDescriptionIntervention
Experimental

Radiation Dose Limitations to VMAT

Patients confirmed to have T1-T3 N1-N3 (Stage IIIA-IIIC) or select Stage IV primary adeno- or squamous cell-carcinoma of the lung will be treated per standard of care; concurrent chemoradiotherapy for 6 to 6.5 weeks, followed by consolidative immunotherapy. A CT simulation scan is obtained with the patient in the treatment position allowing the radiation oncologist to delineate intended tumor targets and organs at risk (OAR). Using specialized treatment planning software, a radiation plan is generated with the goal of maximizing tumor coverage with intended prescription dose and minimizing unintended radiation dose to OARs below established thresholds. The primary intervention of this trial will be sparing the thoracic bone marrow. This will be done by delineating the thoracic bone marrow on the CT simulation scan and applying vertebral marrow-specific OAR constraints during treatment planning to optimally spare radiation dose to this structure during treatment
  • Other: Evidence-based radiation dose limitation to the vertebral bone marrow

    The only intervention that will occur during the radiation treatment planning process will be the application of evidence-based radiation dose limitations to the vertebral bone marrow during treatment plan optimization in order to attempt to limit Grade 3 Lymphopenia (G3L) toxicity.

    •