SBRT in the Management of Solid Spinal Metastases

Study Overview
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Brief Summary
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Documenting efficiency of SBRT in the management of epidural spinal metastases from solid tumors

Detailed Description
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The department of radiotherapy in UZLeuven recently included Stereotactic Body Radiotherapy (SBRT) in the standard of care for the management of patients with spinal metastases. The aim of this study is to prospectively document neurological outcome, performance and quality of life following surgery + SBRT for spinal metastases with imminent / actual spinal cord compression, and compare outcomes with the historical cohort of the UZLeuven patients included in the Global Spine Tumor Study Group database between 2011 and 2019 in whom prospective neurological, performance and quality of life outcomes were collected following surgery + conventional radiotherapy

Official Title
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The Efficiency of SBRT in Preventing Recurrent Spinal Cord Compression in Patients Undergoing Surgery and Radiotherapy for Epidural Spinal Metastasis From Solid Tumor

Conditions
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Extradural Tumor, Spinal Metastases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radiological diagnosis of spinal metastasis from solid tumor with epidural imminent or actual spinal cord compression, with or without neurological deficits. Patients will be scheduled for surgery + SBRT. If contra-indications preclude surgery and only SBRT is performed, patients will still be included. Written informed consent to participate in the study must be obtained from the subject or proxy /legal representative Males and females > 18 years Exclusion Criteria: Any concomitant condition or disease which, in the opinion of the investigator, would affect the reliability of the collected data. Patients that had previous radiotherapy on the index spinal level without the possibility for additional SBRT at that particular level.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurological outcome Frankel scores | Frankel scores (scale form A to E where A= complete loss of motor and sensory function, B= complete motor paralysis but some sensory function, C= some motor function but not usable, D= weakened but usable motor function, E= neurologically intact) | assessed up to 2 weeks prior to surgery | 
| neurological outcome Frankel scores | Frankel scores (scale form A to E where A= complete loss of motor and sensory function, B= complete motor paralysis but some sensory function, C= some motor function but not usable, D= weakened but usable motor function, E= neurologically intact) | assessed up to 2 weeks after surgery | 
| neurological outcome Frankel scores | Frankel scores (scale form A to E where A= complete loss of motor and sensory function, B= complete motor paralysis but some sensory function, C= some motor function but not usable, D= weakened but usable motor function, E= neurologically intact) | every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first | 
| neurological outcome Frankel scores | Frankel scores (scale form A to E where A= complete loss of motor and sensory function, B= complete motor paralysis but some sensory function, C= some motor function but not usable, D= weakened but usable motor function, E= neurologically intact) | every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first | 
| neurological outcome Karnofsky score | Karnofsky score (score from 100 to 10 where 100= no limitations, no complaints, 90= no limitations, minor symptoms, 80= no limitations, some symptoms, 70= care for himself, 60= requires occasional assistance, 50= considerable assistance/frequent care, 40= disabled, 30= severely disabled / hospitalisation, 20= very sick, hospitalisation, active support needed, 10= moribund) | assessed up to 2 weeks prior to surgery | 
| neurological outcome Karnofsky score | Karnofsky score (score from 100 to 10 where 100= no limitations, no complaints, 90= no limitations, minor symptoms, 80= no limitations, some symptoms, 70= care for himself, 60= requires occasional assistance, 50= considerable assistance/frequent care, 40= disabled, 30= severely disabled / hospitalisation, 20= very sick, hospitalisation, active support needed, 10= moribund) | assessed up to 2 weeks after surgery | 
| neurological outcome Karnofsky score | Karnofsky score (score from 100 to 10 where 100= no limitations, no complaints, 90= no limitations, minor symptoms, 80= no limitations, some symptoms, 70= care for himself, 60= requires occasional assistance, 50= considerable assistance/frequent care, 40= disabled, 30= severely disabled / hospitalisation, 20= very sick, hospitalisation, active support needed, 10= moribund) | every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first | 
| neurological outcome Karnofsky score | Karnofsky score (score from 100 to 10 where 100= no limitations, no complaints, 90= no limitations, minor symptoms, 80= no limitations, some symptoms, 70= care for himself, 60= requires occasional assistance, 50= considerable assistance/frequent care, 40= disabled, 30= severely disabled / hospitalisation, 20= very sick, hospitalisation, active support needed, 10= moribund) | every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first | 
| neurological outcome urinary sphincter control | based on patient reporting (normal, impaired, incontinent) | assessed up to 2 weeks prior to surgery | 
| neurological outcome urinary sphincter control | based on patient reporting (normal, impaired, incontinent) | assessed up to 2 weeks after surgery | 
| neurological outcome urinary sphincter control | based on patient reporting (normal, impaired, incontinent) | every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first | 
| neurological outcome urinary sphincter control | based on patient reporting (normal, impaired, incontinent) | every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first | 
| performance and quality of life (EQ5D_3L) questionnaire | data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected | assessed up to 2 weeks prior to surgery | 
| performance and quality of life (EQ5D_3L) questionnaire | data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected | assessed up to 2 weeks after surgery | 
| performance and quality of life (EQ5D_3L) questionnaire | data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected | every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first | 
| performance and quality of life (EQ5D_3L) questionnaire | data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected | every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first |