Trial Information

Phase I/II Evaluation of Single Session Stereotactic Body Radiotherapy for Spinal or Paraspinal Metastases

CT-on-Rails is a system that places the radiation treatment machine in the same room as the
CT scanner so that the CT scanner can help deliver radiation more precisely.

You will have a MRI of the spine within 1 month before registration on this study. You will
also fill out a health survey, a symptom inventory, and a Brief Pain Inventory within 1 week
before registration. Each of these surveys should take about 5 minutes to complete. You
will have a CT-simulation. The simulation is like a CT scan where a special body frame is
used to keep you from moving during scanning and later radiation treatment. However, no
radiation is delivered during the simulation. You will be asked questions about your
medical history and have a complete neurological exam during your first consultation, before
registration. The neurological exam involves testing upper and lower motor strength,
sensation to light touch, reflexes, a mental exam, and an evaluation of the way you walk.

Radiation treatment will last between 2 and 2 1/2 hours and will be given on 1 day about 1
to 1 1/2 weeks after you had the simulation. You will have a device (similar to plastic
wrap) placed around you that will hold you still during the treatment. You will be checked
for level of pain and/or discomfort before starting each session of radiation, and you may
take pain medications before starting each session. All participants will be treated with
radiation therapy that is guided by the CT-on-Rails procedure. On the day of radiation, you
will also receive a CT scan using CT-on-Rails in the same treatment room, immediately before
the radiation treatment.

During treatment, a physician will be monitoring you for any side effects. If you
experience severe side effects, radiation treatment will be stopped, and you will be taken
off study. After treatment on this study ends, you will have telephone, mail, or facsimile
(Fax) follow-ups scheduled at 1, 2, 3, 4, and 8 weeks after radiation. You will be asked
questions about any side effects or pain you are experiencing and any other therapies you
may have started.

You will have follow-up visits scheduled at 3, 6, 9, 12, 18, and 24 months and then every 6
months for the rest of your life. At all follow-up visits, you will be asked questions
about your medical history, have a neurological exam, and your neurologic function will be
evaluated. Any pain medication you are taking will be noted. You will be asked to have a
MRI of the spine at 3, 6, 9, 12,18, and 24 months, then once a year for the rest of your
life. You will also be asked to complete 3 questionnaires to evaluate your symptoms, pain,
and quality of life at each follow-up visit. Each questionnaire should take around 5
minutes to complete.

This is an investigational study. The equipment used in this study are FDA-approved medical
devices and are commercially available. However, the way the devices are being used in this
study is experimental. Up to 60 patients will take part in this study. All will be enrolled
at M. D. Anderson.