Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC

January 13, 2026 updated by: M.D. Anderson Cancer Center
To learn whether giving spinal stereotactic radiosurgery (SRSS) that uses a more advanced imaging scan method called Magnetic Resonance imaging with a Linear Accelerator (MR-LINAC) during treatment will lead to improved responses to treatment and better quality of life. SRSS is radiation therapy given to the area around your spine.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary objective:

• To determine the 6-month local control (LC) of the target site of treatment.

Secondary Objectives:

  • To determine the 6-month change in epidural tumor volume (by volumetric measurements where applicable)
  • To determine the 1-year local control of the target site

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Debra N. Yeboa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA:

  1. Age ≥ 18 years old
  2. Radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed)
  3. Candidate for spine SRS/SBRT as determined by treating Radiation Oncologist or Multidisciplinary Spine Conference review
  4. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed
  5. Diagnosis of cancer documented
  6. Motor strength ≥ 4 out of 5 in the extremity affected by the level of spinal disease planned for radiation
  7. Karnofsky Performance score (KPS) ≥ 40 or ECOG score ≤ 3

EXCLUSION CRITERIA:

  1. Patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc)
  2. Patients who are unable to undergo MRI of the spine with contrast
  3. Patients who are pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (Therapeutic Cohort)
Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.
Procedure: Spine Radiosurgery
scan
Device: Magnetic Resonance imaging
scan
Radiation: MR-LINAC
scan
Experimental: Group 2 (Imaging-only Cohort)
Participants in Group 2 will receive spine radiosurgery using a standard radiation therapy machine and have the opportunity to get imaging on the MR LINAC.
Procedure: Spine Radiosurgery
scan
Device: Magnetic Resonance imaging
scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires
Time Frame: through study completion; an average of 1 year
M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) 0 (symptom has not been present) to 10 (the symptom was as bad as you can imagine it could be) for each item.
through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Debra N. Yeboa, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2023

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0589
  • NCI-2023-00663 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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