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NCT Number: NCT04863612

SBRT in the Management of Solid Spinal Metastases

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

Recruiting

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Key information

Conditions

Extradural Tumor Central Nervous System Diseases Central Nervous System Neoplasms Epidural Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Spinal Cord Diseases Spinal Cord Neoplasms Spinal Metastases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location status: Recruiting

Location contact

Bart Depreitere, Phd MD

CONTACT

[email protected]

+3216344290

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. neurological outcome urinary sphincter control

    Time frame: assessed up to 2 weeks prior to surgery

    based on patient reporting (normal, impaired, incontinent)

  10. neurological outcome urinary sphincter control

    Time frame: assessed up to 2 weeks after surgery

    based on patient reporting (normal, impaired, incontinent)

  11. 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)

  12. 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)

  13. 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

  14. 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

  15. 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

  16. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bart Depreitere, Phd, MD

CONTACT

[email protected]

+3216344290

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2031
Study completion
2036
First posted
Apr 28, 2021
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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