Skip to main content
OpenTrials
Completed

NCT Number: NCT05248256

Vertebral Marrow Attention Trial (VMAT)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt-Ingram Service for Timely Access, Nashville, Tennessee, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evidence-based radiation dose limitation to the vertebral bone marrow

Other

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.

Primary outcomes

  1. Limited G3L Toxicity

    Time frame: 6 weeks

    The primary end point will be evaluating whether implementing dosimetric constraints to the bone marrow will decrease rates of G3L toxicity in the peripheral blood compared to expected rates of 40% in large series examining toxicities during chemoradiation. Values will be expressed as a percentage rates of G3L lymphopenia.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Baseline to study end (up to 5 years)

    Overall Survival (OS), as measured from time of enrollment in the study

  2. Progression free Survival (PFS)

    Time frame: Baseline to study end (up to 5 years)

    Progression Free Survival (PFS), either distant or local measured on routine surveillance imaging

  3. Local Recurrence (LR)

    Time frame: Baseline to study end (up to 5 years)

    Local Recurrence (LR), measured per Response Evaluation Criteria in Solid Tumors (RECIST) criteria on routine imaging,

  4. Metastasis Free Survival (MFS)

    Time frame: Baseline to study end (up to 5 years)

    Metastasis Free Survival (MFS), as measured on surveillance imaging

  5. Change in Neutrophil to Lymphocyte ratio (NLR)

    Time frame: Baseline to study end (up to 5 years)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

Vertebral Bone Marrow in Lung Cancer Attention Trial (VMAT)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 21, 2022
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.