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Vertebroplasty + SBRT for Spinal Cancer Pain Management

N/A
Recruiting
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)
Must not have
Inability or refusal to undergo SBRT treatment or vertebroplasty
Uncontrolled local or systemic infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 1 month, 3 months and 6 months post treatment
Awards & highlights
No Placebo-Only Group

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot or will not undergo SBRT treatment or vertebroplasty.
Select...
I do not have any untreated or uncontrolled infections.
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My cancer is either myeloma, lymphoma, or plasmacytoma.
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I have had radiotherapy on the area now needing treatment.
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I have a blood clotting disorder that cannot be corrected.
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I have severe nerve-related symptoms like weakness or incontinence.
Select...
My spinal issue is too high up (above T4) for safe X-ray guided treatment.
Select...
I have had surgery before on the area that needs treatment.
Select...
My spinal lesion is too big for a certain type of spine surgery.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain change at 1 month
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vertebroplasty
2011
N/A
~420

Find a Location

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,470 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
~26 spots leftby Dec 2025
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