Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University of Texas Southwestern Medical Center
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 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 Inventory. * 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 minutes. Within 1 month after the initiation of SBRT, patients in both groups undergo percutaneous vertebroplasty. 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
