SBRT in the Management of Solid Spinal Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Extradural Tumor, Spinal Metastases. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficiency of SBRT in Preventing Recurrent Spinal Cord Compression in Patients Undergoing Surgery and Radiotherapy for Epidural Spinal Metastasis From Solid Tumor
Overview
Documenting efficiency of SBRT in the management of epidural spinal metastases from solid tumors
Detailed description
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
Primary outcome measures
- neurological outcome Frankel scores [Time frame: assessed up to 2 weeks prior to surgery]
- neurological outcome Frankel scores [Time frame: assessed up to 2 weeks after surgery]
- neurological outcome Frankel scores [Time frame: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first]
- neurological outcome Frankel scores [Time frame: every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first]
- neurological outcome Karnofsky score [Time frame: assessed up to 2 weeks prior to surgery]
- neurological outcome Karnofsky score [Time frame: assessed up to 2 weeks after surgery]
- neurological outcome Karnofsky score [Time frame: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first]
- neurological outcome Karnofsky score [Time frame: every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first]
- neurological outcome urinary sphincter control [Time frame: assessed up to 2 weeks prior to surgery]
- neurological outcome urinary sphincter control [Time frame: assessed up to 2 weeks after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- University hospital Leuven — Leuven
Identifiers
NCT: NCT04863612 · Extradural Tumors