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.
Category
- Cancers and Other Neoplasms
- Lungs, Breathing and Bronchial
- Muscle, Bone and Cartilage
- IRB Number
- 20210892HU
- NCT Number
- NCT05248256
- Open to Enrollment
- Yes
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
Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu
Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu
Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu
Regulatory Point of Contact
Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu
Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu
Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu
Regulatory Point of Contact
Pia Ashley Roperes
(210) 450-5626
roperes@uthscsa.edu
Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu
Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu
Principal Investigator
Neil Newman