SBRT in the Management of Solid Spinal Metastases

Recruiting

• Conditions: Extradural Tumor; Spinal Metastases

• Registration Number: NCT04863612
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-04-23
• Study First Posted: 2021-04-28
• Study Start: 2021-05-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2023-12-29
• Primary Completion: 2031-03-01
• Study Completion: 2036-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
neurological outcome Karnofsky score	every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first	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)
performance and quality of life (EQ5D_3L) questionnaire	every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first	data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected
neurological outcome Frankel scores	every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first	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)
neurological outcome urinary sphincter control	every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first	based on patient reporting (normal, impaired, incontinent)

Trial Locations

Locations (1)

University hospital Leuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium