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Increased Early Pain Relief by Adding Vertebroplasty to SBRT

RecruitingNAAges 18 Years - anyAllCentre hospitalier de l'Université de Montréal (C…
NCT05317026 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Vertebroplasty
  • Stereotactic Body Radiation Therapy only
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Where

2 sites
CHUM
Montreal, Canada
Véronique Freire
Montreal, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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