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Compares treatment options for Solid Tumor
Official title Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases
ClinicalTrials.gov ID: NCT06613295
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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.
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium
- Brasschaat, Belgium
- Edegem, Belgium
- Genk, Belgium
- Hasselt, Belgium
- Kortrijk, Belgium
- Mechelen, Belgium
- Sint-Niklaas, Belgium
- Wilrijk, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalst, Belgium; Brasschaat, Belgium; Edegem, Belgium; Genk, Belgium; Hasselt, Belgium; Kortrijk, Belgium and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.