Actively Recruiting
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
Led by Cancer Research Antwerp · Updated on 2024-09-25
128
Participants Needed
9
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how stereotactic ablative body radiotherapy (SABR) alone compares to separation surgery followed by SABR in patients with malignant epidural spinal cord compression (MESCC) who can walk with or without aid. This randomized controlled trial focuses on maintaining walking ability three months after treatment, with additional goals including local tumor control, progression-free survival, pain relief, quality of life, and the need for further interventions. Participants are randomly assigned to one of two groups: one receives separation surgery followed by SABR, and the other receives SABR alone. Surgery aims to remove tumor tissue pressing on the spinal cord to allow safer radiation delivery. SABR is given in five treatment sessions, each delivering specific radiation doses to targeted areas. Surgery is scheduled within 21 days post-randomization, and SABR starts within 21 days either after surgery or alone. Throughout the study, participants are closely monitored through various methods including MRI scans, clinical evaluations, questionnaires on quality of life and pain, and teleconsultations at multiple time points up to two years after treatment. These assessments track ambulatory function, treatment side effects, tumor control, need for additional treatments, and survival. The total study period includes screening, treatment, and follow-up phases lasting up to 24 months.
CONDITIONS
Brief 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 confirmed by histology or spinal surgical procedure
- Age 18 years or older
- Evidence of spinal metastasis by histology, radiology, or scintigraphy
- Spinal instability neoplastic score (SINS) less than 13, indicating no need for spinal stabilization
- Spinal metastasis with malignant epidural spinal cord compression (MESCC) at Bilsky grade 1c, 2, or 3
- Ambulatory status: able to walk 10 meters with or without aid (cane, rollator, or one person's help)
- Estimated life expectancy of at least 3 months
- World Health Organization (WHO) Performance Status between 0 and 2
- Provided written informed consent
You will not qualify if you...
- Contraindication for MRI scan, such as having a pacemaker
- Previous radiation therapy or surgery at the affected vertebrae
- Non-solid primary tumors like lymphoma, multiple myeloma, or germ cell tumors
- Non-ambulatory at the time of presentation
- More than 3 affected vertebrae in one target site
- More than 2 treatment sites
- Spinal instability neoplastic score (SINS) of 13 or higher indicating an unstable spine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 21 days after randomisation; SABR delivered in 5 fractions
Participants receive either separation surgery followed by stereotactic ablative body radiotherapy (SABR) or SABR alone to treat spinal metastases.
1 surgery visit (if assigned) and 5 SABR treatment visits
Duration - Up to 24 months post treatment
Participants are monitored for ambulatory status, toxicity, need for re-intervention, pain response, quality of life, local control, and survival up to 24 months after treatment.
Visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months post treatment (in-person or digital consults)
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
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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