Lung Cancer Clinical Trial
Vertebral Marrow Attention Trial (VMAT)
Summary
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 Criteria
Inclusion Criteria:
Adult patient > 18 years
Patients with AJCC (American Joint Committee on Cancer) 8 T1-T4, N1-N3, M0 stage IIIA-IIIC NSCLC (non small cell lung cancer)
Patients with oligometastatic disease stage IV, M1 disease, in which definitive concurrent chemoradiotherapy to the thorax is planned
CBC/CMP within these limits
Absolute lymphocyte count>500/ml
Hemoglobin>8 g/dL
AST (aspartate aminotransferase)/ALT (alanine transaminase) <2.5 times of ULN
Eastern Cooperative Oncology Group (ECOG) 0-2
Exclusion Criteria:
History of thoracic irradiation
History of palliative radiation for the current malignancy under consideration
Patients not being treated with definitive standard of care 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
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