Vertebral Marrow Attention Trial (VMAT)

The University of Texas Health Science Center at San Antonio12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

Evidence-based radiation dose limitation to the vertebral bone marrowOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Vanderbilt-Ingram Service for Timely Access

Nashville, Tennessee, United States

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Limited G3L Toxicity

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.

Time frame: 6 weeks