SBRT Spine: Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis

Study ID
STU 072010-134

Cancer Related

Healthy Volunteers

Study Sites

  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Parkland Health & Hospital System

Susan Cooley

Principal Investigator
Robert Timmerman, M.D.


Subjects will be assigned according to their history of radiation to different fractions of SBRT. Those with no prior radiation to the site will receive 1 fraction of SBRT. Those with prior radiation to site will receive 5 fractions of SBRT. once SBRT is complete, all patients will undergo vertebroplasty. The treatment period could last up to 69 days or be as little as 2 days. Subjects will then be seen in follow-up visits at the end of all treatment: one, three, and six months, and then every six months for three years.

about 42 people total will take part in this study from uT Southwestern and Parkland Health and Hospital System. 29 patients with no prior history of radiation to the spine and 13 patients with a prior history of radiation to the affected spine will be enrolled.

Participant Eligibility

- 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 had a visual analog scoring of pain >=4 at the planned treated site within 14 days of registration. Pain must be ongoing or require narcotic pain medicine to control.
- 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
- platelet count must be >= 50,000