Actively Recruiting
The Efficiency of SBRT in Preventing Recurrent Spinal Cord Compression in Patients Undergoing Surgery and Radiotherapy for Epidural Spinal Metastasis From Solid Tumor
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2023-12-29
100
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Stereotactic Body Radiotherapy (SBRT) in managing epidural spinal metastases from solid tumors. This observational study aims to document neurological outcomes, physical performance, and quality of life after surgery combined with SBRT for patients with imminent or actual spinal cord compression. These results will be compared with historical data from patients treated with surgery and conventional radiotherapy between 2011 and 2019 at UZLeuven. Participants will undergo surgery followed by SBRT as part of their treatment for spinal metastases. If surgery is not possible due to contraindications, patients may receive SBRT alone and still be included in the study. The study tracks neurological function and quality of life using standardized assessments at multiple time points before surgery, shortly after surgery, and during follow-up visits for up to five years. Participants will complete neurological evaluations including Frankel scores, Karnofsky scores, and urinary sphincter control assessments before surgery, two weeks after surgery, every three months for one year, and yearly up to five years or until death. Quality of life is also assessed using the EQ5D_3L questionnaire following the same schedule. The study involves long-term monitoring to understand the effects of SBRT combined with surgery or alone on patient outcomes.
CONDITIONS
Brief Title
SBRT in the Management of Solid Spinal Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Radiological diagnosis of spinal metastasis from solid tumor with imminent or actual epidural spinal cord compression, with or without neurological deficits
- Patients scheduled for surgery plus SBRT or SBRT alone if surgery is contraindicated
- Written informed consent obtained from the participant or legal representative
- Male or female aged over 18 years
You will not qualify if you...
- Any condition or disease that may affect the reliability of collected data as judged by the investigator
- Previous radiotherapy on the same spinal level without possibility for additional SBRT at that level
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until discharge
Participants undergo surgery for spinal metastases with imminent or actual spinal cord compression followed by immediate post-operative care.
Assessments up to 2 weeks before and after surgery
Duration - Duration as per standard care
Participants receive Stereotactic Body Radiotherapy (SBRT) as part of their management for spinal metastases.
Visit schedule as per clinical care; not specified in the trial
Duration - Up to 5 years or until death
Participants are assessed regularly to monitor neurological outcomes, performance, and quality of life following surgery and SBRT.
Visits every 3 months for the first year, then annually up to 5 years
Trial Site Locations
Total: 1 location
1
University hospital Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Actively Recruiting
Research Team
B
Bart Depreitere, Phd, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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