Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal… (NCT00855803) | Clinical Trial Compass
CompletedPhase 2
Stereotactic Body Radiation Therapy and Vertebroplasty in Treating Patients With Localized Spinal Metastasis
United States35 participantsStarted 2009-02
Plain-language 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 compression caused by spinal metastasis. Giving stereotactic body radiation therapy together with vertebroplasty may help lessen pain and improve quality of life of patients with spinal metastasis.
PURPOSE: This phase II trial is studying how well giving stereotactic body radiation therapy together with vertebroplasty works in treating patients with localized spinal metastasis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 i…
What they're measuring
1
Pain Response as Measured by VAS at 3 Months
Timeframe: 3 month
Trial details
NCT IDNCT00855803
SponsorUniversity of Texas Southwestern Medical Center