Combining vertebroplasty with radiation therapy for spine metastases pain relief
Pre-irradiation Vertebroplasty in Patients With Spine Metastases Candidates for SBRT vs SBRT Alone: Increased Early Pain Relief
This study is testing whether combining a procedure to strengthen the spine with radiation therapy can help people with spine cancer feel less pain and lower their chances of fractures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT05317026 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of adding vertebroplasty to stereotactic body radiation therapy (SBRT) for patients with spinal metastases. The primary goal is to enhance pain relief and reduce the risk of fractures in patients receiving SBRT. Participants will be evaluated for pain levels and quality of life following the interventions. The study aims to determine if vertebroplasty performed before SBRT can lead to better outcomes compared to SBRT alone.
Who should consider this trial
Good fit: Ideal candidates include patients with spinal metastases who experience moderate to severe pain and are eligible for SBRT.
Not a fit: Patients with certain types of cancer, previous surgeries at the treatment site, or severe neurological signs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and quality of life for patients with spinal metastases.
How similar studies have performed: While the combination of vertebroplasty and SBRT is not well documented, similar approaches in pain management have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montreal, Quebec and 1 other locations
- Chum — Montreal, Quebec, Canada (Recruiting)
- Véronique Freire — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Véronique Freire, MD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Véronique Freire, MD
- Email: veronique.freire.med@ssss.gouv.qc.ca
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.