Status:
COMPLETED
Effect of Samarium on the Relief of Pain Due to Vertebral Metastases
Lead Sponsor:
New York Presbyterian Brooklyn Methodist Hospital
Conditions:
Cancer
Metastasis
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Cancer cells may spread from the primary site to the vertebrae resulting in their deformity. The standard treatment for this case is removal of the cancer deposits in the vertebra and filling the indu...
Detailed Description
Protocol: 1. Patients with bone metastases will be identified and discussed in the weekly joint Neuroscience meeting held in Radiation Oncology Department. 2. If the patient is eligible to this study...
Eligibility Criteria
Inclusion
- The patient must be 18 years of age or older
- The patient must have histologically proven malignancy in the primary site (breast, prostate, or lung)
- The patient must have a radiographic evidence of bone metastasis, and this must have been performed within 8 weeks prior to enrollment in the study. Acceptable studies include plain radiographs, radionuclide bone scans, computed tomography scans, magnetic resonance imaging, and PET-CT scans.
- The patient must have an intact anterior wall of spinal canal
- The patient must have significant pain (score 6 or above,)which appears to be related to the radiographically documented metastatic vertebra(e) in concern, as measured by the "Visual Analog Scale"
- The patient must be surgically and medically accepted for vertebroplasty/kyphoplasty operation
- Karnofsky Performance status \>40
- Expected life expectancy of 6 months or greater, as estimated by the physician in charge.
- The patient must sign a study specific informed consent prior to enrollment
Exclusion
- Epidural soft tissue component
- Patients with vertebral metastases and with clinical or radiographic evidence of spinal cord or cauda equina impingement (effacement) or compression
- Inability to undergo anesthesia
- Hematologic primary malignancies Patients received systemic radiotherapy (89SR or 153SM)within 30 days prior to enrollmen
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00374751
Start Date
May 1 2006
End Date
January 1 2016
Last Update
August 26 2019
Active Locations (1)
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1
New York Methodist Hospital
Brooklyn, New York, United States, 11215