Comparing surgery followed by radiation to radiation alone for spinal tumors

Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy Versus Stereotactic Ablative Body Radiotherapy Alone for Spinal Metastases Invading the Spinal Canal: a Randomised, Non-inferiority Trial

This study is testing whether surgery followed by radiation or radiation alone is better for helping people with spinal tumors keep their ability to walk three months after treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cancer Research Antwerp (Academic / other)
• Locations: 9 sites (Aalst and 8 other locations)
• Trial ID: NCT06613295 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are ambulatory adults aged 18 and older with a diagnosis of solid malignant tumors and MESCC.

Not a fit: Patients with non-solid primary tumors or those requiring prior surgery or radiation at the affected vertebrae may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive treatment option for patients with spinal tumors while maintaining mobility.

How similar studies have performed: Other studies have explored similar approaches, but this specific comparison of SABR with and without surgery is novel.

Eligibility criteria

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 this trial is running

Aalst and 8 other locations

• 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)

Study contacts

• Principal investigator: Charlotte Billiet, MD, PhD — ZAS Augustinus
• Study coordinator: Charlotte Billiet, MD, PhD

Conditions Solid Tumor; Spinal Neoplasms; Spinal Tumor