Actively Recruiting
Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases
Led by Cancer Research Antwerp · Updated on 2024-09-25
128
Participants Needed
9
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of a solid malignant tumour (preferably confirmed by tissue sample or spinal surgery)
- Age 18 years or older
- Evidence of spinal metastasis by histology, imaging, or bone scan
- Spinal instability neoplastic score (SINS) less than 13 (no spine stabilization needed)
- Spinal metastasis with malignant epidural spinal cord compression (MESCC) grade 1c, 2, or 3
- Able to walk 10 meters with or without aid (cane, rollator, or help from another person)
- Life expectancy of at least 3 months
- WHO Performance Status of 0 to 2 (some help allowed)
- Provided written informed consent
You will not qualify if you...
- Unable to have an MRI scan (e.g., due to pacemaker)
- Prior radiation therapy or surgery at the affected vertebrae
- Non-solid primary tumors (such as lymphoma, multiple myeloma, germ cell tumors)
- Unable to walk at the time of presentation
- More than 3 affected vertebrae in one target site
- More than 2 treatment sites
- Spinal instability neoplastic score (SINS) 13 or higher (unstable spine)
AI-Screening
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Trial Site Locations
Total: 9 locations
1
OLVZ Aalst
Aalst, Belgium
Not Yet Recruiting
2
AZ Klina
Brasschaat, Belgium
Not Yet Recruiting
3
UZA
Edegem, Belgium
Not Yet Recruiting
4
ZOL
Genk, Belgium
Actively Recruiting
5
Jessa
Hasselt, Belgium
Not Yet Recruiting
6
AZ Groeninge
Kortrijk, Belgium
Not Yet Recruiting
7
AZ Sint-Maarten
Mechelen, Belgium
Not Yet Recruiting
8
VITAZ
Sint-Niklaas, Belgium
Actively Recruiting
9
GZA
Wilrijk, Belgium
Actively Recruiting
Research Team
C
Charlotte Billiet, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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