Phase I Study of Feasibility of Single Session Spine Stereotactic Radiosurgery (SSRS) in the Primary Management in Patients With Inoperable, Previously Unirradiated Metastatic Epidural Spinal Cord Compression (MESCC)
Spinal cord compression is often treated with surgery followed by radiation in small doses
everyday for a number of days. When a patient cannot or will not have surgery, radiation is
given daily. With increased accuracy and precision, higher doses of radiation can be given
in a single session. Giving a higher dose in a single session may increase the chance that
the tumor will stop growing into the spinal canal and will prevent spinal cord injury.
This study will also help to identify the tolerance of the spinal cord to radiation in a
Spine Stereotactic Radiosurgery:
You will lie in the mold that was made for you for 45-120 minutes while you receive your
You will have follow-up visits at Months 3 (+/-2 weeks ), 6 (+/-4 weeks), 9 (+/-4 weeks), 12
(+/-8 weeks), 18 (+/-8 weeks), and 24 (+/-8 weeks) and then every 6 months after that. At
each follow-up visit:
- Your medical history will be recorded, including any use of steroids.
- You will have a neurological exam.
- You will complete the 3 questionnaires about health, symptoms you may be having, and
- You will have an MRI of the spine (except for Month 1).
If you are unable to return for follow-up clinic visits, you will be called and asked about
your medical history, and you will complete the 3 questionnaires about your health, symptoms
you may be having, and about pain. This call should take about 20 minutes.
Length of Study:
Your treatment will last 1 day. You will continue having follow-up visits or phone calls for
as long as possible.
This is an investigational study. SSRS is FDA approved. The use of SSRS to treat
metastatic epidural spinal cord compression is investigational.
Up to 36 patients will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Occurrences of Paralysis caused by Radiation Myelitis (RM)
Up to 12 months following radiation
Stephen Settle, MD,PHD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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