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

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

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)

Conditions4

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