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Vertebral Marrow Attention Trial (VMAT)

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Evidence-based radiation dose limitation to the vertebral bone marrow
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt-Ingram Service for Timely AccessRecruiting
  • Mays Cancer Center, UT Health San AntonioRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation Dose Limitations to VMAT

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 13, 2022
Last Updated
October 4, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT05248256
Brief Title
Vertebral Marrow Attention Trial (VMAT)
Official Title
Vertebral Bone Marrow in Lung Cancer Attention Trial (VMAT)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2022 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiation Dose Limitations to VMAT
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Evidence-based radiation dose limitation to the vertebral bone marrow
Intervention Description
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 Outcome Measure Information:
Title
Limited G3L Toxicity
Description
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
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall Survival (OS), as measured from time of enrollment in the study
Time Frame
Baseline to study end (up to 5 years)
Title
Progression free Survival (PFS)
Description
Progression Free Survival (PFS), either distant or local measured on routine surveillance imaging
Time Frame
Baseline to study end (up to 5 years)
Title
Local Recurrence (LR)
Description
Local Recurrence (LR), measured per Response Evaluation Criteria in Solid Tumors (RECIST) criteria on routine imaging,
Time Frame
Baseline to study end (up to 5 years)
Title
Metastasis Free Survival (MFS)
Description
Metastasis Free Survival (MFS), as measured on surveillance imaging
Time Frame
Baseline to study end (up to 5 years)
Title
Change in Neutrophil to Lymphocyte ratio (NLR)
Time Frame
Baseline to study end (up to 5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Epp Goodwin
Phone
210-450-5798
Email
goodwine@uthscsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carol Jenkins
Phone
210-450-5924
Email
JenkinsCA@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Newman, MD
Organizational Affiliation
The University of Texas Health Science Center - Mays Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Service for Timely Access
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evan Osmundson, MD
Phone
800-811-8480
Email
cip@vumc.org
First Name & Middle Initial & Last Name & Degree
Evan Osmundson, MD
Facility Name
Mays Cancer Center, UT Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Epp Goodwin
Phone
210-450-1000
Email
goodwine@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Carol Jenkins
Phone
210-450-5924
Email
JenkinsCA@uthscsa.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Vertebral Marrow Attention Trial (VMAT)

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