Vertebral Marrow Attention Trial (VMAT)
NCT05248256 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2024-10-30
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
The University of Texas Health Science Center at San Antonio
lead OTHER
Principal Investigators
-
Neil Newman, MD · The University of Texas Health Science Center - Mays Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-29
- Primary Completion
- 2024-07-12
- Completion
- 2024-09-18
Countries
- United States
Study Locations
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