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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Spinal Disease

Intervention / Treatment
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* Procedure: Spine Radiosurgery
* Device: Magnetic Resonance imaging
* Radiation: MR-LINAC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (Therapeutic Cohort)<br>Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine. | Procedure: Spine Radiosurgery<br>* scan<br>Device: Magnetic Resonance imaging<br>* scan<br>Radiation: MR-LINAC<br>* scan<br>|
| Experimental: Group 2 (Imaging-only Cohort)<br>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<br>* scan<br>Device: Magnetic Resonance imaging<br>* scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| M. D. Anderson Symptom Inventory - Spine Tumor (MDASI-SP) questionnaires | 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 |