Comparing surgery followed by radiation to radiation alone for spinal tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of stereotactic ablative body radiotherapy (SABR) alone versus SABR following separation surgery in patients with malignant epidural spinal cord compression (MESCC). The study aims to determine which approach better preserves ambulatory function three months after treatment. Participants will be randomly assigned to one of two groups: one receiving separation surgery followed by SABR and the other receiving SABR alone. Secondary outcomes include local control, progression-free survival, quality of life, and pain management.

Why it matters

Who can join: the full rules

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)

Where it's running

• Zol
  Genk, Belgium Recruiting
• Vitaz
  Sint-Niklaas, Belgium Recruiting
• Gza
  Wilrijk, Belgium Recruiting
• OLVZ Aalst
  Aalst, Belgium Not yet recruiting
• AZ Klina
  Brasschaat, Belgium Not yet recruiting
• Uza
  Edegem, Belgium Not yet recruiting

Study contacts

• Principal investigator: Charlotte Billiet, MD, PhD — ZAS Augustinus
• Study coordinator: Charlotte Billiet, MD, PhD
• Email: gza.cancertrials@zas.be
• Phone: 03234433759

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.