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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)
Timeline
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 belowSelect...
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.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week, 1 month, 3 months and 6 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 1 month, 3 months and 6 months post treatment
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 moreTrial 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
366 Previous Clinical Trials
129,587 Total Patients Enrolled
Véronique Freire, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer diagnosis was confirmed through tissue examination.I cannot or will not undergo SBRT treatment or vertebroplasty.I do not have any untreated or uncontrolled infections.I can care for myself but may not be able to do active work.My cancer is either myeloma, lymphoma, or plasmacytoma.I have had radiotherapy on the area now needing treatment.My spine is unstable due to a tumor, as confirmed by a high SINS score or a tumor board.I have a blood clotting disorder that cannot be corrected.My cancer has spread to the bones in my spine.I am a candidate for targeted radiation therapy.My spine has potentially unstable cancer-related lesions.I have severe nerve-related symptoms like weakness or incontinence.My spinal issue is too high up (above T4) for safe X-ray guided treatment.I have had surgery before on the area that needs treatment.My spinal lesion is too big for a certain type of spine surgery.My pain from cancer spread is 4 or more on a scale of 0 to 10.
Research Study Groups:
This trial has the following groups:- Group 1: V-SBRT
- Group 2: SBRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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