Randomized Study of Stereotactic Body Radiotherapy vs. Conventional Radiation for Spine Metastasis

• Pain Control as measured by NPRS [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Determine if image-guided radiosurgery/SBRT improves pain control as measured by NPRS as compared to conventional external beam radiotherapy
  
  

• Duration of pain response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Determine whether image-guided radiosurgery/SBRT increases the duration of pain response at the treated site(s), as compared to conventional external beam radiotherapy, as measured by NPRS
  
  
• Adverse Events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Compare adverse events between the two treatments according to the criteria in the CTEP Active Version of CTCAE
  
  
• Quality of Life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Evaluate potential benefit of image-guided radiosurgery/SBRT on change in and overall quality of life as measured by FACT-G, BPI and EQ-5D
  
  
• Long Term Effects of image-guided radiosurgery/SBRT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Long term effects of image-guided radiosurgery/SBRT on the vertevral bone and spinal cord
  
  
• Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Progrsesion Free and Overall Survival
  
  

Randomization means that you are put into a group by chance. It is like flipping a coin. Neither you nor the research doctor will choose what group you will be in.

You will have a 2 to 1 chance of being placed in the SBRT to standard radiation group. Since SBRT is the newer treatment being tested, we would like to include more patients in this group.

Treatment Procedures:

SBRT: You may receive one, three or five SBRT treatments depending on the extent of your cancer. During each treatment you will be assessed by a nurse and a physician for a physical and neurological assessment. The treatment itself would last approximately I hour where you will be lying on a treatment table. Prior to each treatment you will have a physical and neurological assessment by a physician. Standard Radiation: You will receive ten consecutive working days of standard radiation. While each treatment lasts five to ten minutes, the entire visit may last up to thirty minutes. During the treatment you will be lying on a treatment table. Once per week you will have a physical and neurological assessment by your treating physician After the final treatment of the study therapy: We would like to keep track of your medical condition for at least 12 months after you receive treatment. We would like to do this by having you come in to the clinic at months 1, 3, 6, 12 and 24 months after treatment*. At these visits we will be looking for the same information as during the screening time frame. This includes:

• A history and physical from you
• A Performance Status of how you are able to carry on with your usual activities.
• A Pain scale questionnaire called the Numerical Rating Pain Scale(NRPS) that asks to explain your pain symptoms on a 0-10 scale
• 3 Quality Of Life (QOL) Assessments described below:
• Functional Assessment of Cancer Therapy-General (FACT-G)
• The Brief Pain Inventory (BPI)
• The EuroQOL (EQ-5D)
• An assessment of your tumor by MRI (Magnetic Resonance Imaging)