SBRT in the Management of Solid Spinal Metastases

Universitaire Ziekenhuizen KU Leuven100 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Extradural Tumor Spinal Metastases

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

University hospital Leuven

Leuven, Vlaams Brabant, Belgium

RECRUITING

Outcomes

Primary Outcomes

neurological outcome Frankel scores

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)

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

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)

Time frame: assessed up to 2 weeks prior to surgery

Central Contacts

Bart Depreitere, Phd, MD

CONTACT

+3216344290 bart.depreitere@uzleuven.be

Data from ClinicalTrials.gov

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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

based on patient reporting (normal, impaired, incontinent)

Time frame: assessed up to 2 weeks prior to surgery

neurological outcome urinary sphincter control

based on patient reporting (normal, impaired, incontinent)

Time frame: assessed up to 2 weeks after surgery

neurological outcome urinary sphincter control

based on patient reporting (normal, impaired, incontinent)

Time frame: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first

neurological outcome urinary sphincter control

based on patient reporting (normal, impaired, incontinent)

Time frame: every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first

performance and quality of life (EQ5D_3L) questionnaire

data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected

Time frame: assessed up to 2 weeks prior to surgery

performance and quality of life (EQ5D_3L) questionnaire

data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected

Time frame: assessed up to 2 weeks after surgery

performance and quality of life (EQ5D_3L) questionnaire

data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected

Time frame: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first

performance and quality of life (EQ5D_3L) questionnaire

data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected

Time frame: every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first