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

NCT06613295 · tracked via the Priya Life Science Belgium tracker

Sponsor

Cancer Research Antwerp

Phase

Not applicable

Started

2022-03-07

Last updated

2024-09-25

Condition(s) studied

Solid TumorSpinal NeoplasmsSpinal Tumor

Investigational drug(s) / intervention(s)

SABRSeparation surgery

SABR: SABR

Separation surgery: Separation surgery

Study summary

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 surgery" followed by SABR (5x 8.0 Gy postoperative) (control arm) vs. SABR alone (5x 8.0 Gy) (study arm).

Patients will be evaluated at 3 and 6 months after treatment with MRI scan, quality of life questionnaires, anamnestic and clinical evaluation at clinical follow ups for assessment of ambulatory function, acute and late toxicity and need for reintervention. Moreover, at 6 weeks, 12 months and 24 months after treatment a teleconsult for assessment of ambulatory function, and need for reintervention will be performed.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Proportion of ambulant patients at 3 months — 3 Months post treatment
The ambulatory status is scored binary (without or with aid vs not being able to walk)

Trial sites (9)

Facility	City	Region	Status
OLVZ Aalst	Aalst	Belgium	Not Yet Recruiting
AZ Klina	Brasschaat	Belgium	Not Yet Recruiting
UZA	Edegem	Belgium	Not Yet Recruiting
ZOL	Genk	Belgium	Recruiting
Jessa	Hasselt	Belgium	Not Yet Recruiting
AZ Groeninge	Kortrijk	Belgium	Not Yet Recruiting
AZ Sint-Maarten	Mechelen	Belgium	Not Yet Recruiting
VITAZ	Sint-Niklaas	Belgium	Recruiting
GZA	Wilrijk	Belgium	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06613295 on ClinicalTrials.gov ↗ ← All trials in Belgium