Separation Surgery Followed by Stereotactic Ablative Body Radiotherapy (SABR) Versus SABR Alone for Spinal Metastases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Research Antwerp
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
SABR
RadiationSABR
Separation surgery
Procedure/SurgerySeparation surgery
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Separation surgery followed by stereotactic ablative body radiotherapyActive comparator 2 interventions
Group B: Stereotactic ablative body radiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of ambulant patients at 3 months
The ambulatory status is scored binary (without or with aid vs not being able to walk)
Time frame
3 Months post treatmentSecondary outcomes
1
Local recurrence rate
Time between date of study registration and date of local recurrence
Time frame
Up to 24 months post treatment2
Time to loss of ambulation
Time between date of study registration and date of loss of ambulation (in days)
Time frame
Up to 24 months post treatment3
Progression free survival (PFS)
Time between date of study registration and date of local recurrence
Time frame
Up to 24 months post treatment4
Overall survival
Time between date of study registration and date of death of any cause or last follow-up
Time frame
Up to 24 months post treatmentSponsors and contacts
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Source ClinicalTrials.gov