SBRT in the Management of Solid Spinal Metastases

NCT04863612 | Recruiting

• 1 other identifier: Extradural Tumors
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Extradural Tumor; Spinal Metastases

Outcome Measures

Primary Outcomes (16)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• neurological outcome urinary sphincter control

  based on patient reporting (normal, impaired, incontinent)

  assessed up to 2 weeks prior to surgery

• neurological outcome urinary sphincter control

  based on patient reporting (normal, impaired, incontinent)

  assessed up to 2 weeks after surgery

• 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

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University hospital Leuven

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Epidural Neoplasms

Condition Hierarchy (Ancestors)

Spinal Cord Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Bart Depreitere, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bart Depreitere, Phd, MD

CONTACT

+3216344290; bart.depreitere@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: April 28, 2021
• Study Start: May 18, 2021
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2036
• Last Updated: December 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)