SBRT in the Management of Solid Spinal Metastases

Spinal Metastases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04863612
• Other study ID #: Extradural Tumors
• Status: Recruiting
• Start date: May 18, 2021
• Est. completion date: March 1, 2036

Study information

• Verified date: November 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Bart Depreitere, Phd, MD
• Phone: +3216344290
• Email: bart.depreitere[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2036
• Est. primary completion date: March 1, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Metastases

Locations

Country	Name	City	State
Belgium	University hospital Leuven	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	assessed up to 2 weeks prior to surgery
Primary	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)	assessed up to 2 weeks after surgery
Primary	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)	every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first
Primary	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)	every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first
Primary	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)	assessed up to 2 weeks prior to surgery
Primary	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)	assessed up to 2 weeks after surgery
Primary	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)	every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first
Primary	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)	every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first
Primary	neurological outcome urinary sphincter control	based on patient reporting (normal, impaired, incontinent)	assessed up to 2 weeks prior to surgery
Primary	neurological outcome urinary sphincter control	based on patient reporting (normal, impaired, incontinent)	assessed up to 2 weeks after surgery
Primary	neurological outcome urinary sphincter control	based on patient reporting (normal, impaired, incontinent)	every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first
Primary	neurological outcome urinary sphincter control	based on patient reporting (normal, impaired, incontinent)	every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first
Primary	performance and quality of life (EQ5D_3L) questionnaire	data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected	assessed up to 2 weeks prior to surgery
Primary	performance and quality of life (EQ5D_3L) questionnaire	data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected	assessed up to 2 weeks after surgery
Primary	performance and quality of life (EQ5D_3L) questionnaire	data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected	every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first
Primary	performance and quality of life (EQ5D_3L) questionnaire	data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected	every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first