Status:
COMPLETED
Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Metastatic Cancer
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Vertebroplasty may help prevent fractures and spinal cord compre...
Detailed Description
OBJECTIVES: Primary * To determine the efficacy of stereotactic body radiotherapy in reducing pain at 3 months in patients with localized spinal metastasis. Secondary * To determine the duration o...
Eligibility Criteria
Inclusion
- Eligibility:
- Inclusion:
- Patients must have localized spine metastasis (a solitary spine metastasis; two contiguous levels, or up to three separate single vertebral levels are permitted)
- Patients must have a VAS of ≥4 at any of the planned treatment sites
- Patient with epidural, spinal nerve, and/or cord compression on MRI may be included
- Histologic confirmation of cancer is required by biopsy, prior surgery, or re-biopsy
- Narcotic pain prescription and usage information must be available and documented
- Patients must sign study specific consent
- Above the age of 18
- For women of childbearing age a negative pregnancy test is required
- Patients considered for the retreatment arm, must not of had prior radiation to the proposed spinal site within a 3 month interval prior to treatment
- Zubrod score of 0-2
- Exclusion:
- Patients who have been non-ambulatory for more than 7 days
- Patients with compression fractures
- Spine instability requiring fixation
- Patients with paraspinal extension
- Patients with bony fragments
- Planned systemic treatment within one week after treatment.
- Absence of pathological diagnosis of cancer
- Chemotherapy within one week of treatment
- Patients with Multiple Myeloma, Lymphoma, or Plasmacytoma
- Patient suffered from unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Patient had a transmural myocardial infarction within the last 6 months
- Patient has an acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Patient has hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
- PT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
- PTT is not within normal limits or planned and feasible to be corrected to normal limits prior to vertebroplasy
- Platelet count is \< 50,000
- History of significant psychiatric illness
- Note: Vertebroplasty may not be possible for certain patients due to tumor location or safety. In such cases, patients will omit the vertebroplasty but receive all other protocol care and follow-up Visual Analog Scoring
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 20 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00855803
Start Date
February 1 2009
End Date
January 20 2021
Last Update
March 16 2022
Active Locations (1)
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1
University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390