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Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases

RecruitingNAAges 18 Years - anyAllCancer Research Antwerp
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In plain words

What the trial is, and whether it could suit you

This is a non-inferiority, randomised controlled trial to investigate the effect of stereotactic ablative body radiotherapy (SABR) compared to separation surgery followed by SABR in ambulatory patients with malignant epidural spinal cord compression (MESCC). The primary objective of the project is investigating the effect of SABR compared to separation surgery followed by SABR in ambulatory patients with MESCC on retaining ambulatory function. The primary endpoint of the study is ambulatory function 3 months post treatment defined as: being able to walk 10m without aid; being able to walk 10m with aid (cane, rollator, one persons help, …); not being able to walk. Secondary outcomes are local control, progression free survival, early and late adverse effects, quality of life, effect on pain and need for reintervention. The aim is to randomise 128 patients 1:1 to either "separation surge

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of a solid malignant tumour (preferentially histologically proven;alternatively obtained by spinal surgical procedure) * Age 18 years or older * Histological, radiological or scintigraphical evidence of spinal metastasis (no limitation in the number of sites of metastases) * Spinal instability neoplastic score (SINS) \<13 (i.e. no need for stabilisation of the spine) (see Appendix 6) * Spinal metastasis with MESCC: ESCC grade 1c, 2 and 3 (see Appendix 7) * Ambulatory: being able to walk 10m without aid or with aid (cane, rollator, one persons help). * Life expectancy estimated to be at least 3 months. * World Health Organization (WHO) Performance Status of 0-2 (some help) (see Appendix 3) * Patient has given written informed consent. Exclusion Criteria: * Contra indication for MRI scan (e.g. pacemaker) * Previous RT or surgery at the level of the affected vertebrae * Non-solid primary tumours (e.g. lymphoma, multiple myeloma, germ cell tumours) * Non ambulatory at presentation * More than 3 affected vertebrae in one target site * More than 2 treatment sites * SINS ≥ 13 (unstable spine)
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What it tests

  • SABR
  • Separation surgery
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Where

9 sites
OLVZ Aalst
Aalst, Belgium
AZ Klina
Brasschaat, Belgium
UZA
Edegem, Belgium
ZOL
Genk, Belgium
Jessa
Hasselt, Belgium
AZ Groeninge
Kortrijk, Belgium
AZ Sint-Maarten
Mechelen, Belgium
VITAZ
Sint-Niklaas, Belgium

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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