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NCT Number: NCT05709782

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

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.

Recruiting

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Key information

Conditions

Spinal Disease Bone Diseases Musculoskeletal Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Debra N. Yeboa, MD

PRINCIPAL_INVESTIGATOR

Debra Yeboa, MD

CONTACT

[email protected]

713-563-2415

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Spine Radiosurgery

Procedure

scan

Magnetic Resonance Imaging

Device

scan

MR-LINAC

Radiation

scan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Debra N. Yeboa, MD

CONTACT

[email protected]

(713) 563-2415

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Feb 2, 2023
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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