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Vertebroplasty + Radiotherapy for Vertebral Metastasis

Phase 3
Waitlist Available
Led By Juan F Asenjo, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biopsy-proven breast cancer (BC) or prostate cancer (PC)
Between 35 and 75 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up listed at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
Awards & highlights

Study Summary

This trial is testing if adding a vertebroplasty (a medical procedure where cement is injected into the spine) to radiotherapy helps treat spine metastasis from breast and prostate cancer better than radiotherapy alone.

Who is the study for?
This trial is for adults aged 35-75 with breast or prostate cancer that has spread to the spine, causing pain and possibly fractures. Participants must have a confirmed diagnosis, evidence of spinal metastases in certain areas, and be able to communicate in English, French, or Spanish.Check my eligibility
What is being tested?
The study tests whether combining vertebroplasty (injecting cement into the spine) with radiotherapy offers better pain relief and activity levels than just radiotherapy alone for patients with vertebral metastasis from breast or prostate cancer.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, increased risk of new fractures near treated vertebrae due to changes in spine mechanics, and possible complications from bone cement like leakage or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed diagnosis of breast or prostate cancer.
Select...
I am between 35 and 75 years old.
Select...
My MRI shows I have small fractures in my spine.
Select...
My cancer has spread to my spine.
Select...
I have back pain above 5/10 due to cancer spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after
This trial's timeline: 3 weeks for screening, Varies for treatment, and recorded at 1 week, 2 weeks, 4 weeks, 3 months, 6 months, 1 year after 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 relief; score on pain questionnaire
Secondary outcome measures
cost of medical care
new vertebral fractures
pain medication
+3 more

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
440 Previous Clinical Trials
159,088 Total Patients Enrolled
3 Trials studying Pain
236 Patients Enrolled for Pain
Juan F Asenjo, MDPrincipal InvestigatorMontreal General Hospital
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Radiotherapy Clinical Trial Eligibility Overview. Trial Name: NCT00294151 — Phase 3
Pain Research Study Groups:
Pain Clinical Trial 2023: Radiotherapy Highlights & Side Effects. Trial Name: NCT00294151 — Phase 3
Radiotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT00294151 — Phase 3

Frequently Asked Questions

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

Are there any restrictions for participants in this research?

"The study's ideal candidate is somebody between the ages of 35 and 75 that has experienced pain related to metastases in the past. Additionally, they should have a Verbal Analog Scale reading greater than 5/10."

Answered by AI

Is this research project still recruiting participants?

"No, this study is not currently enrolling patients as per the clinicaltrials.gov website. The trial was first posted on September 1st, 2005 but has not been updated since July 12th, 2007. There are however 4,929 other trials that are recruiting patients at the moment."

Answered by AI

Are there any severe negative side effects associated with this medication?

"This Phase 3 trial provides some evidence of efficacy and extensive safety data, so our team at Power has rated the safety as a 3."

Answered by AI

Can adults over the age of 20 participate in this research study?

"This trial is only for people aged 35 to 75. Out of the 4701 trials available for patients over 65, this one is unique. And out of the 261 trials meant for those under 18, this is also the only one that meets these specifications."

Answered by AI
~2 spots leftby Mar 2025