Status:
RECRUITING
Increased Early Pain Relief by Adding Vertebroplasty to SBRT
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Conditions:
Spine Metastases
Radiation Therapy
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05317026
Start Date
November 22 2023
End Date
December 31 2027
Last Update
August 7 2024
Active Locations (2)
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1
CHUM
Montreal, Quebec, Canada, H2X0C1
2
Véronique Freire
Montreal, Quebec, Canada