SBRT in the Management of Solid Spinal Metastases

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04863612

Enrollment

100

Registered

2021-04-28

Start date

2021-05-18

Completion date

2036-03-01

Last updated

2023-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extradural Tumor, Spinal Metastases

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
neurological outcome Frankel scores	assessed up to 2 weeks prior to surgery	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 Karnofsky score	assessed up to 2 weeks prior to surgery	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)
neurological outcome urinary sphincter control	assessed up to 2 weeks prior to surgery	based on patient reporting (normal, impaired, incontinent)
performance and quality of life (EQ5D_3L) questionnaire	assessed up to 2 weeks prior to surgery	data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected

Countries

Belgium

Contacts

Primary ContactBart Depreitere, Phd, MD

bart.depreitere@uzleuven.be+3216344290

Outcome results