SBRT in the Management of Solid Spinal Metastases

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SBRT in the Management of Solid Spinal Metastases

Study Purpose

Documenting efficiency of SBRT in the management of epidural spinal metastases from solid tumors

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years - 99 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04863612
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Universitaire Ziekenhuizen KU Leuven
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bart Depreitere, MD, PhD
Principal Investigator Affiliation	UZ Leuven
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Belgium
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Extradural Tumor, Spinal Metastases

Additional Details

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

Contact a Trial Team

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