Pain, Radiation Therapy, Spine Metastases
Conditions
Brief summary
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.
Interventions
PROCEDUREVertebroplasty
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.
PROCEDUREStereotactic Body Radiation Therapy only
SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological evidence of cancer. * Spinal and vertebral bone metastases (T5 to L5) documented by imaging. * Pain related to metastases ≥ 4 on a numerical scale 0-10. * Karnofsky performance index \> 60 (ecog 0-2) * Candidate for SBRT * Less than 3 consecutive levels reached. * Ability to complete follow-up questionnaires regarding pain, analgesics, and quality of life assessment. * Potentially unstable lesions according to the spinal instability neoplastic score (SINS) scale (\> or = 7)
Exclusion criteria
* Pregnancy or breastfeeding. * Contraindications to MRI. * Histology: myeloma, lymphoma or plasmacytoma. * Radiotherapy prior to the level to be treated. * Previous surgery at the site to be treated. * Surgical indication: spinal instability neoplastic score (SINS) \> 13 or according to tumor board consensus. Bilsky score \> or = 2 Severe or progressive neurological signs (motor, incontinence). * Lesion too large for safe vertebroplasty. * High thoracic location not allowing safe visibility in fluoroscopy to perform vertebroplasty (T4 and above). * Non-reversible coagulation disorders. * Uncontrolled local or systemic infection. * Estimated survival of less than 6 months. * Inability or refusal to undergo SBRT treatment or vertebroplasty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain change at 1 month | 1 month following the treatment | Visual Analogue Scale, from 0 to 10, 10 being the highest pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain change | 1 week, 1 month, 3 months and 6 months post treatment | Visual Analogue Scale, from 0 to 10, 10 being the highest pain |
| Change in level of physical, psychological and social functions | at 1 week, 1 month, 3 months and 6 months post treatment | EORTC Quality of life Questionnaire : QLQ-C30 (score between 0 and 100, highest numbers represents higher response and quality of life) |
| Change in symptoms related to bone metastasis | at 1 week, 1 month, 3 months and 6 months post treatment | 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) |
| Change in performance for activities of daily living | at 1 week, 1 month, 3 months and 6 months post treatment | Karnofsky performance scale (score from 0 to 100, the lower the Karnofsky score, themore disable the patient is and need assistance) |
| Post-treatment fracture rates | at 3, 6, 12 and 24 months post treatment | evaluation by MRI +/- CT imaging |
Countries
Canada
Contacts
CONTACTVéronique Freire, MD
CONTACTFidaa Al-Shakfa, M.sc.
PRINCIPAL_INVESTIGATORVéronique Freire, MD
Centre hospitalier de l'Université de Montréal (CHUM)
Outcome results
None listed