The goal of treating metastases is to preserve stability and neurological function while reducing pain. The actual standard of care is stereotaxic body radiation therapy (SBRT) alone in non-surgical patients. The added value of vertebroplasty to SBRT is not well documented in the literature, nor whether performing vertebroplasty before radiotherapy treatment leads to a reduction in the rate of fractures and post-SBRT pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume. The vertebroplasty will be performed according to the usual procedure at the center in the angiography suite under local anesthesia and conscious sedation * Introduction of a vertebral needle, under biplanar fluoroscopic guidance, polymethylmethacrylate (PMMA) cement injection. * Cone-beam volume-CT at the end of the procedure, with the angiography table and c-arm, to evaluate the cement distribution and detect any leak. * Decubitus position for 2 hours following procedure, then hospital discharge on the same day.
SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume
CHUM
Montreal, Quebec, Canada
RECRUITINGVéronique Freire
Montreal, Quebec, Canada
RECRUITINGPain change at 1 month
Visual Analogue Scale, from 0 to 10, 10 being the highest pain
Time frame: 1 month following the treatment
Pain change
Visual Analogue Scale, from 0 to 10, 10 being the highest pain
Time frame: 1 week, 1 month, 3 months and 6 months post treatment
Change in level of physical, psychological and social functions
EORTC Quality of life Questionnaire : QLQ-C30 (score between 0 and 100, highest numbers represents higher response and quality of life)
Time frame: at 1 week, 1 month, 3 months and 6 months post treatment
Change in symptoms related to bone metastasis
QLQ-Bone metastases : BM22 questionnaire (All of the scales range in score from 0 to 100. A high score for the symptom scales represents a high level of symptomatology or problems, whilst a high score for the functional scales represents a high level of functioning)
Time frame: at 1 week, 1 month, 3 months and 6 months post treatment
Change in performance for activities of daily living
Karnofsky performance scale (score from 0 to 100, the lower the Karnofsky score, themore disable the patient is and need assistance)
Time frame: at 1 week, 1 month, 3 months and 6 months post treatment
Post-treatment fracture rates
evaluation by MRI +/- CT imaging
Time frame: at 3, 6, 12 and 24 months post treatment
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