Find-A-Study

Vertebral Bone Marrow in Lung Cancer Attention Trial (VMAT) (CTMS# 21-0168)

Lay Description

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.

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

Arm Groups

Study Contact

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

Principal Investigator
Neil Newman