RecruitingNot Applicable

SBRT in the Management of Solid Spinal Metastases

Belgium100 participantsStarted 2021-05-18

Plain-language summary

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

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

neurological outcome Frankel scores

Timeframe: assessed up to 2 weeks prior to surgery

neurological outcome Frankel scores

Timeframe: assessed up to 2 weeks after surgery

neurological outcome Frankel scores

Timeframe: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first

neurological outcome Frankel scores

Timeframe: every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first

neurological outcome Karnofsky score

Timeframe: assessed up to 2 weeks prior to surgery

neurological outcome Karnofsky score

Timeframe: assessed up to 2 weeks after surgery

neurological outcome Karnofsky score

Timeframe: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first

neurological outcome Karnofsky score

Trial details

NCT IDNCT04863612

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-03-01

Contact for this trial

Bart Depreitere, Phd, MD

+3216344290 bart.depreitere@uzleuven.be

View on ClinicalTrials.gov More Extradural Tumor trials

Who can participate

Age range18 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

neurological outcome Frankel scores

Timeframe: assessed up to 2 weeks prior to surgery

neurological outcome Frankel scores

Timeframe: assessed up to 2 weeks after surgery

neurological outcome Frankel scores

Timeframe: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first

neurological outcome Frankel scores

Timeframe: every year, from 1 year after surgery until date of decease or up to 5 years, whichever came first

neurological outcome Karnofsky score

Timeframe: assessed up to 2 weeks prior to surgery

neurological outcome Karnofsky score

Timeframe: assessed up to 2 weeks after surgery

neurological outcome Karnofsky score

Timeframe: every 3 months, from date of surgery until date of decease or up to 1 year, whichever came first

neurological outcome Karnofsky score