NCT05248256Completed
Vertebral Marrow Attention Trial (VMAT)
Vertebral Bone Marrow in Lung Cancer Attention Trial (VMAT)
Source: ClinicalTrials.gov · Last updated 30 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 13 Jan 2022
- Start date
- Sept 2022
- Primary completion date
- Jul 2024
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Diseases
- Lung cancer
- NCT number
- NCT05248256
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From Sept 2022 to the primary completion date, Jul 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients not being treated with definitive standard of care to the chest
- History of prior cytotoxic chemotherapy for a disease other than for the current malignancy
- Administration of concurrent immunotherapy during radiation therapy, either as part of another clinical trial or otherwise
Other illness
- History of thoracic irradiation
- History of palliative radiation for the current malignancy under consideration
- History of bone marrow disease and or leukemia
- Polymetastatic disease, defined here as ≥3 or more extrathoracic metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vanderbilt-Ingram Service for Timely Access Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Mays Cancer Center, UT Health San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.