Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis
Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional treatment trial for Metastatic Cancer focused on measuring spinal cord metastases, unspecified adult solid tumor, protocol specific, pain
Eligibility Criteria
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
Sites / Locations
- University of Texas Southwestern Medical Center - Dallas
Arms of the Study
Arm 1
Experimental
Radiation followed by Vertebroplasty
Intervention: This study is one arm. All patients will undergo radiotherapy followed by vertebroplasty. Patients who had prior radiotherapy will undergo 5 fractions of stereotactic body radiotherapy (SBRT) over 30-90 minutes each. Patients has no prior radiotherapy will undergo 1 fraction of SBRT over 30-90 minutes. The full patient population will then undergo vertebroplasty*. *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.