Vertebral Marrow Attention Trial (VMAT)

Lung Cancer Clinical Trial

Official title:

Vertebral Bone Marrow in Lung Cancer Attention Trial (VMAT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05248256
• Other study ID #: CTMS# 21-0168
• Secondary ID: HSC20210892H
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2022
• Est. completion date: August 2026

Study information

• Verified date: October 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Epp Goodwin
• Phone: 210-450-5798
• Email: goodwine[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Service for Timely Access	Nashville	Tennessee
United States	Mays Cancer Center, UT Health San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival (OS)	Overall Survival (OS), as measured from time of enrollment in the study	Baseline to study end (up to 5 years)
Secondary	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)
Secondary	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)
Secondary	Metastasis Free Survival (MFS)	Metastasis Free Survival (MFS), as measured on surveillance imaging	Baseline to study end (up to 5 years)
Secondary	Change in Neutrophil to Lymphocyte ratio (NLR)		Baseline to study end (up to 5 years)