SBRT in the Management of Solid Spinal Metastases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
Documenting efficiency of SBRT in the management of epidural spinal metastases from solid tumors
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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)
Time frame
assessed up to 2 weeks prior to surgery2
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)
Time frame
assessed up to 2 weeks after surgery3
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)
Time frame
every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first4
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)
Time frame
every year, from 1 year after surgery until date of decease or up to 5 years, whichever came firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov