Clinical trial NCT04863612: SBRT in the Management of Solid Spinal Metastases
Official title: The Efficiency of SBRT in Preventing Recurrent Spinal Cord Compression in Patients Undergoing Surgery and Radiotherapy for Epidural Spinal Metastasis From Solid Tumor
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Extradural Tumor
Spinal Metastases
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: males and females older then 18 years with radiological diagnosis of spinal metastais from solid tumor with epidural imminent or actual spinal cord compression with or without neurological deficits planned for surgery and SBRT.

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

Eligibility 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.

Primary outcomes:
measure: neurological outcome Frankel scores
timeFrame: assessed up to 2 weeks prior to surgery
measure: neurological outcome Frankel scores
timeFrame: assessed up to 2 weeks after surgery
measure: neurological outcome Frankel scores
timeFrame: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first
measure: neurological outcome Frankel scores
timeFrame: every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first
measure: neurological outcome Karnofsky score
timeFrame: assessed up to 2 weeks prior to surgery
measure: neurological outcome Karnofsky score
timeFrame: assessed up to 2 weeks after surgery
measure: neurological outcome Karnofsky score
timeFrame: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first
measure: neurological outcome Karnofsky score
timeFrame: every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first
measure: neurological outcome urinary sphincter control
timeFrame: assessed up to 2 weeks prior to surgery
measure: neurological outcome urinary sphincter control
timeFrame: assessed up to 2 weeks after surgery
measure: neurological outcome urinary sphincter control
timeFrame: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first
measure: neurological outcome urinary sphincter control
timeFrame: every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first
measure: performance and quality of life (EQ5D_3L) questionnaire
timeFrame: assessed up to 2 weeks prior to surgery
measure: performance and quality of life (EQ5D_3L) questionnaire
timeFrame: assessed up to 2 weeks after surgery
measure: performance and quality of life (EQ5D_3L) questionnaire
timeFrame: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first
measure: performance and quality of life (EQ5D_3L) questionnaire
timeFrame: every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University hospital Leuven
state: Vlaams Brabant
Study officials:
affiliation: UZ Leuven
name: Bart Depreitere, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: