Extradural TumorNCT04863612
SBRT in the Management of Solid Spinal Metastases
An observational study of Extradural Tumor and Spinal Metastases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Documenting efficiency of SBRT in the management of epidural spinal metastases from solid tumors Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Extradural Tumor, Spinal Metastases
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 18 May 2021to 1 Mar 2036
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University hospital Leuven
Leuven, Vlaams Brabant, 3000
Bart Depreitere, Phd MD, +3216344290, bart.depreitere@uzleuven.be
About this study
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
Documenting efficiency of SBRT in the management of epidural spinal metastases from solid tumors
Read the 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
- Conditions
- Extradural Tumor, Spinal Metastases
- Medical subject headings
- Epidural Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: assessed up to 2 weeks prior to surgery
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)
Measured: assessed up to 2 weeks after surgery
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)
Measured: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first
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)
Measured: 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)
Measured: assessed up to 2 weeks prior to surgery
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)
Measured: assessed up to 2 weeks after surgery
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)
Measured: every 3 months, from date of surgery until date of decease or up to 1 year, 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)
Measured: 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)
Measured: assessed up to 2 weeks prior to surgery
neurological outcome urinary sphincter control
based on patient reporting (normal, impaired, incontinent)
Measured: assessed up to 2 weeks after surgery
neurological outcome urinary sphincter control
based on patient reporting (normal, impaired, incontinent)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start18 May 2021
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Mar 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extradural TumorStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bart Depreitere, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863612
- Sponsor's protocol ID
- Extradural Tumors
- Status last verified
- Nov 2023
- First submitted
- 19 Feb 2021
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04863612
- Acronym / sponsor ID
- Extradural Tumors
- Conditions
- Extradural Tumor, Spinal Metastases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 18 May 2021 (actual)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Mar 2036 (estimated)
- First posted
- 28 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
neurological outcome Frankel scores
Time frame: 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 Frankel scores
Time frame: assessed up to 2 weeks after 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 Frankel scores
Time frame: every 3 months, from date of surgery until date of decease or up to 1 year, 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 Frankel scores
Time frame: 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 Karnofsky score
Time frame: 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 Karnofsky score
Time frame: assessed up to 2 weeks after 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 Karnofsky score
Time frame: every 3 months, from date of surgery until date of decease or up to 1 year, 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)
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
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
Time frame: assessed up to 2 weeks prior to surgery
based on patient reporting (normal, impaired, incontinent)
neurological outcome urinary sphincter control
Time frame: assessed up to 2 weeks after surgery
based on patient reporting (normal, impaired, incontinent)
neurological outcome urinary sphincter control
Time frame: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first
based on patient reporting (normal, impaired, incontinent)
neurological outcome urinary sphincter control
Time frame: 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)
performance and quality of life (EQ5D_3L) questionnaire
Time frame: assessed up to 2 weeks prior to surgery
data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected
performance and quality of life (EQ5D_3L) questionnaire
Time frame: assessed up to 2 weeks after surgery
data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected
performance and quality of life (EQ5D_3L) questionnaire
Time frame: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first
data concerning mobility, self-care, usual activities, pain and discomfort, anxiety and depression will be collected
performance and quality of life (EQ5D_3L) questionnaire
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bart Depreitere, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extradural Tumor and Spinal Metastases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bart Depreitere, Phd, MD (+3216344290, bart.depreitere@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neurological outcome Frankel scores (time frame: assessed up to 2 weeks prior to surgery). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.