Status:
UNKNOWN
Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Breast Cancer
Prostate Cancer
Eligibility:
All Genders
35-75 years
Phase:
PHASE3
Brief Summary
The study aims to evaluate if adding vertebroplasty to radiotherapy, in the treatment of spine metastasis from breast and prostate cancer, is preferable to radiotherapy alone. The investigators hypoth...
Detailed Description
Included patients presenting with spinal metastasis secondary to breast or prostate cancer are randomized to two groups, intervention and control. Both groups receive standard radiotherapy, which is c...
Eligibility Criteria
Inclusion
- Between 35 and 75 years old
- Biopsy-proven breast cancer (BC) or prostate cancer (PC)
- Radiographic evidence of spine metastases from the BC or PC in the lumbar and/or mid-low thoracic spine
- Microfractures or compression fractures up to 40% of the original height of the vertebral body in an MRI \[magnetic resonance imaging\] (reported by an independent radiologist)
- Incidental back pain (Verbal Analog Scale \> 5/10) felt to be related to those metastases
Exclusion
- Spinal cord compression
- Massive rupture of the posterior wall of the vertebral body (according to blinded radiological report)
- Coagulopathy (International Normalized Ratio \[INR\] \> 1.5, platelets \< 80,000)
- Inability to communicate in English, French or Spanish
- Previous radiotherapy to the spine in the area presently affected
- Mental cognitive impairment
- Vertebral metastasis without fracture in the MRI
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00294151
Start Date
September 1 2005
Last Update
July 13 2007
Active Locations (1)
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1
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4