Vertebral Marrow Attention Trial (VMAT)

NCT05248256 | Completed

• 2 other identifiers: CTMS# 21-0168HSC20210892H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Overall Survival (OS)

  Baseline to study end (up to 5 years)

• Progression free Survival (PFS)

  Baseline to study end (up to 5 years)

• Local Recurrence (LR)

  Baseline to study end (up to 5 years)

• Metastasis Free Survival (MFS)

  Baseline to study end (up to 5 years)

• Change in Neutrophil to Lymphocyte ratio (NLR)

  Baseline to study end (up to 5 years)

Study Arms (1)

Radiation Dose Limitations to VMAT

EXPERIMENTAL

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

Interventions

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.

Radiation Dose Limitations to VMAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (2)

Vanderbilt-Ingram Service for Timely Access

Nashville, Tennessee, 37232, United States

Location

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Neil Newman, MD

  The University of Texas Health Science Center - Mays Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 21, 2022
• Study Start: September 29, 2022
• Primary Completion: July 12, 2024
• Study Completion: September 18, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Locations

US (2)