Pre-irradiation Vertebroplasty in Patients With Spine Metastases Candidates for SBRT vs SBRT Alone: Increased Early Pain Relief

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Canada
CHUM
RECRUITING
Montreal
Véronique Freire
RECRUITING
Montreal
Contact Information
Primary
Véronique Freire, MD
veronique.freire.med@ssss.gouv.qc.ca
514-890-8000
Backup
Fidaa Al-Shakfa, M.sc.
f.alshakfa.crchum@gmail.com
514-890-8000
Time Frame
Start Date: 2023-11-22
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 50
Treatments
Experimental: V-SBRT
Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT)
Other: SBRT
SBRT is the actual standard of care.
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov