Definitive Radiation for High-Risk Spine Metastases

Study Overview
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Brief Summary
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This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery

Official Title
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A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases

Conditions
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Metastatic Cancer, Metastatic Lung Cancer, Metastatic Breast Cancer, Metastatic Tumor, Metastatic Tumor of Bone, Metastatic Tumor to the Spine, Spine Metastases, Metastasis

Intervention / Treatment
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* Radiation: SBRT to the spine


Participation Criteria
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Eligibility Criteria
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Eligible patients must have: Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease Metastatic spine involvement documented by imaging Involvement of maximum 3 contiguous vertebral bodies at the index site Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids An evaluation by an radiation oncology and orthopedic spine/neurosurgery attending ECOG Performance Status of 0-3 Patients are ineligible if they have: An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12 Had previous surgery or radiation to address the target spinal metastases Radiosensitive tumors (e.g. small cell lung cancer, lymphoma, multiple myeloma, and germ-cell tumors)

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT to the spine<br> | Radiation: SBRT to the spine<br>* Stereotactic body radiation therapy (SBRT) administered to spine metastases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of spinal surgery/stabilization within 6 months following SBRT | Assess the efficacy of spine SBRT alone in controlling spine metastases | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in epidural tumor volume | Percent reduction of epidural volume of the treated metastatic lesions | 3 months | 
| Changes on Neck Disability index | The NDI measures neck pain and disabilities in patients with neck pain | 1 months, 3 months, 6 months | 
| Changes on Oswestry Low Back Disability Questionnaire | The Oswestry Disability Index measures disability in patients with low back pain | 1 months, 3 months, 6 months | 
| Changes on EQ-5D-5L questionnaire | The EuroQol 5D-5L questionnaire measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | 1 months, 3 months, 6 months | 
| Progression-free survival |  | 6 months | 
| Overall survival |  | 6 months |