Trial Information

Phase I/II Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) for the Treatment of Metastatic Spine Disease

CT-On-Rails or Trilogy 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 of registration on this study. You will
also fill out a health survey (5 minutes), a symptom inventory ( 5 minutes), and a Brief
Pain Inventory (5 minutes) within 1 week of registration.

A pretreatment feasibility study will first be performed to determine the precision,
accuracy, and reproducibility with which the target volume and critical normal structures
(e.g. spinal cord) can be positioned relative to the radiation beams for spine tumors; this
will consist of a CT scan.

Patients will have a CT-simulation. The simulation is like a CT scan where a special body
frame is used to keep the patient from moving during scanning and later treatment.

You will be asked questions about your medical history and have a complete neurological exam
during your first consultation. The neurological exam involves testing upper and lower motor
strength, sensation to light touch, reflexes, mental exam, and way you walk. MRI of the
spine must be performed within 1 month of registration. You will be asked to complete 3
questionnaires to evaluate your symptoms and pain. Each questionnaire will take around 5
minutes to complete, and should be completed within 1 month of being enrolled in the study.

All patients will be treated with radiation therapy that is guided by the CT-on-Rails or
Trilogy procedure. Patients will receive a CT scan immediately before the treatment in the
same room of the treatment using CT-On-Rails or Trilogy. There will be a total of 3
treatments over a period of 2 weeks.

Monitoring of side effects will be focused on neurological, gastrointestinal,
musculoskeletal, and hematological systems. Every attempt will be made to have the patient
complete the prescribed course of radiation to maximize the beneficial effect of treatment.
However, if there is severe side effects, radiation treatment will be stopped and patients
will be taken off study.

You will have follow up visits once a week during radiation treatment, scheduled on the same
day as radiation. After treatment, you will have telephone, mail, or follow-ups per fax
scheduled at 2 and 4 weeks,and 2 months post radiation. You will have follow up visits
scheduled at 3, 6, 9, 12, 18, and 24 months, then every six 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 neurologic function will be evaluated. Any pain medication
you are taking will be noted. You will have an 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 and pain. Each questionnaire will take around 5
minutes to complete.

This is an investigational study. The CT-on-rails and Trilogy linear accelerator are
FDA-approved medical devices and are commercially available, however, the way these two
devices are being used is investigational. Up to 150 patients will take part in this study.
All will be enrolled at M. D. Anderson.