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Vertebroplasty + SBRT for Spinal Cancer Pain Management

Led By Véronique Freire, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histological evidence of cancer
Karnofsky performance index > 60 (ecog 0-2)
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 1 month, 3 months and 6 months post treatment
Awards & highlights

Study Summary

This trial aims to determine if vertebroplasty, a type of surgery, before SBRT leads to a reduction in the rate of fractures and post-SBRT pain.

Who is the study for?
This trial is for adults with cancer-related spinal pain, unstable spine lesions, and confirmed spinal metastases from T5 to L5. They must be able to handle radiation therapy, have a decent performance status (Karnofsky >60), and can't have more than 3 consecutive affected spine levels. Excluded are those with infections, MRI contraindications, prior treatments at the same site, large lesions or coagulation issues, severe neurological symptoms, certain cancer types like myeloma or lymphoma, pregnant/breastfeeding women or very short life expectancy.Check my eligibility
What is being tested?
The study tests if adding vertebroplasty (a procedure that stabilizes the spine) before standard stereotactic body radiation therapy (SBRT) provides better early pain relief for patients with painful spinal bone metastases compared to SBRT alone.See study design
What are the potential side effects?
Potential side effects include discomfort at the injection site from vertebroplasty and typical radiation therapy side effects such as fatigue and skin irritation. There may also be risks of new fractures or nerve damage due to the procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My cancer diagnosis was confirmed through tissue examination.
I can care for myself but may not be able to do active work.
My cancer has spread to the bones in my spine.
My spine has potentially unstable cancer-related lesions.
My pain from cancer spread is 4 or more on a scale of 0 to 10.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 1 month, 3 months and 6 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 1 month, 3 months and 6 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain change at 1 month
Secondary outcome measures
Change in level of physical, psychological and social functions
Change in performance for activities of daily living
Change in symptoms related to bone metastasis
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: V-SBRTExperimental Treatment1 Intervention
Vertebroplasty followed by Stereotactic Body Radiation Therapy (SBRT)
Group II: SBRTExperimental Treatment1 Intervention
SBRT is the actual standard of care.
First Studied
Drug Approval Stage
How many patients have taken this drug

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,587 Total Patients Enrolled
Véronique Freire, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)

Media Library

Stereotactic Body Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05317026 — N/A
Spinal Metastases Research Study Groups: V-SBRT, SBRT
Spinal Metastases Clinical Trial 2023: Stereotactic Body Radiation Therapy Highlights & Side Effects. Trial Name: NCT05317026 — N/A
Stereotactic Body Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05317026 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is access to this experiment currently available for those seeking participation?

"The study described in clinicaltrials.gov is no longer accepting enrollees as of 11/11/2022, even though it was initially posted on 12/4/2022. Nevertheless, 982 other trials are currently seeking participants at this time."

Answered by AI
~25 spots leftby Apr 2025