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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-SBRT | Experimental | Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT) |
|
| SBRT | Other | SBRT is the actual standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vertebroplasty | Procedure | 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
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain change at 1 month | Visual Analogue Scale, from 0 to 10, 10 being the highest pain | 1 month following the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pain change | Visual Analogue Scale, from 0 to 10, 10 being the highest pain | 1 week, 1 month, 3 months and 6 months post treatment |
| Change in level of physical, psychological and social functions |
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Inclusion Criteria:
Exclusion Criteria:
spinal instability neoplastic score (SINS) > 13 or according to tumor board consensus.
Bilsky score > or = 2 Severe or progressive neurological signs (motor, incontinence).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Véronique Freire, MD | Contact | 514-890-8000 | veronique.freire.med@ssss.gouv.qc.ca | |
| Fidaa Al-Shakfa, M.sc. | Contact | 514-890-8000 | f.alshakfa.crchum@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Véronique Freire, MD | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUM | Recruiting | Montreal | Quebec | H2X0C1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42032732 | Derived | Giguere P, Bahig H, Westra S, Roberge D, Bourque JM, Masucci GL, Nkurunziza ES, Freire V, Belliveau C, Duplan D, Vigneault E, Wong P, Lang P, Menard C. Platform for the Evaluation of innovations in Radiation oncology through registry-based conduct of multi-centric pragmatic randomized trials: PERa implementation. Trials. 2026 Apr 24;27(1):437. doi: 10.1186/s13063-026-09709-0. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054854 | Vertebroplasty |
| ID | Term |
|---|---|
| D060826 | Cementoplasty |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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|
| Stereotactic Body Radiation Therapy only | Procedure | SBRT consists of radiotherapy treatments hypofractionated in 1 to 5 fractions, at doses considered curative at a precise target volume |
|
|
EORTC Quality of life Questionnaire : QLQ-C30 (score between 0 and 100, highest numbers represents higher response and quality of life)
| 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) | 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) | at 1 week, 1 month, 3 months and 6 months post treatment |
| Post-treatment fracture rates | evaluation by MRI +/- CT imaging | at 3, 6, 12 and 24 months post treatment |
| Véronique Freire | Recruiting | Montreal | Quebec | Canada |
|