Vertebral Marrow Attention Trial (VMAT)

Vertebral Bone Marrow in Lung Cancer 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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Evidence-based radiation dose limitation to the vertebral bone marrow

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt-Ingram Service for Timely Access
  • Texas
    • San Antonio, Texas, United States, 78229
      • Mays Cancer Center, UT Health San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radiation Dose Limitations to VMAT; Patients confirmed to have T1-T3 N1-N3 (Stage IIIA-IIIC) or select Stage IV primary adeno- or squamous cell-carcinoma of the lung will be treated per standard of care; concurrent chemoradiotherapy for 6 to 6.5 weeks, followed by consolidative immunotherapy. A CT simulation scan is obtained with the patient in the treatment position allowing the radiation oncologist to delineate intended tumor targets and organs at risk (OAR). Using specialized treatment planning software, a radiation plan is generated with the goal of maximizing tumor coverage with intended prescription dose and minimizing unintended radiation dose to OARs below established thresholds. The primary intervention of this trial will be sparing the thoracic bone marrow. This will be done by delineating the thoracic bone marrow on the CT simulation scan and applying vertebral marrow-specific OAR constraints during treatment planning to optimally spare radiation dose to this structure during treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall Survival (OS), as measured from time of enrollment in the study	Baseline to study end (up to 5 years)
Progression free Survival (PFS)	Progression Free Survival (PFS), either distant or local measured on routine surveillance imaging	Baseline to study end (up to 5 years)
Local Recurrence (LR)	Local Recurrence (LR), measured per Response Evaluation Criteria in Solid Tumors (RECIST) criteria on routine imaging,	Baseline to study end (up to 5 years)
Metastasis Free Survival (MFS)	Metastasis Free Survival (MFS), as measured on surveillance imaging	Baseline to study end (up to 5 years)
Change in Neutrophil to Lymphocyte ratio (NLR)		Baseline to study end (up to 5 years)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Neil Newman, MD, The University of Texas Health Science Center - Mays Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2022
• Primary Completion (Actual): July 12, 2024
• Study Completion (Actual): September 18, 2024

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: CTMS# 21-0168; HSC20210892H (Other Identifier: UT Health San Antonio)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No