Phase II Study of Stereotactic Body Radiation Therapy and Vertebroplasty for Localized Spinal Metastasis (SBRT Spine)
- To determine the efficacy of stereotactic body radiotherapy in reducing pain at 3
months in patients with localized spinal metastasis.
- To determine the duration of pain response at the treated site(s) scored as the time of
maximal pain relief to an increase of 2 points on the Visual Analogue Scoring System.
- To determine the functional preservation of improvement as measured by the Brief Pain
- To prospectively assess quality of life using the FACT-G and EQ-5D questionnaires.
- To determine the long-term stability of the treated vertebral bone (e.g., fracture,
sclerotic change, vertebral body height, or malalignment) as measured by MRI, CT scan,
and plain radiographs.
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to prior radiotherapy to
the planned treatment site(s).
- Group 1 (prior radiotherapy): Patients undergo 5 fractions of stereotactic body
radiotherapy (SBRT) over 30-90 minutes each.
- Group 2 (no prior radiotherapy): Patients undergo 1 fraction of SBRT over 30-90
Within 1 month after the initiation of SBRT, patients in both groups undergo percutaneous
Patients complete pain and quality-of-life questionnaires at baseline and periodically
during study. Patients also undergo MRI and CT scan at baseline, at 1, 3, and 6 months, and
then every 6 months for 3 years to assess changes in vertebral bone strength and stability.
After completion of study therapy, patients are followed at 2 weeks, at 1, 3, and 6 months,
and then every 6 months for 3 years.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Pain reduction as measured by Visual Analogue Scoring System (VAS) at 3 months
Robert D. Timmerman, MD
Simmons Cancer Center
United States: Food and Drug Administration
|University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|