Trial Information

Randomized Ph II Study of Stereotactic Body Radiotherapy (SBRT) Versus Conventional Radiation for Spine Metastasis

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)