Status:
COMPLETED
Vertebral Marrow Attention Trial (VMAT)
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05248256
Start Date
September 29 2022
End Date
September 18 2024
Last Update
October 30 2024
Active Locations (2)
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1
Vanderbilt-Ingram Service for Timely Access
Nashville, Tennessee, United States, 37232
2
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, United States, 78229