Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00269 | Registry Identifier | NCI CTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical study is to learn the feasibility of using a single session of radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural spinal cord compression.
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 single session.
Spine Stereotactic Radiosurgery:
You will lie in the mold that was made for you for 45-120 minutes while you receive your radiation treatment.
Follow-up Visits:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Radiosurgery (SSRS) | Experimental | Target dose of 18 or 24 Gy to spine in single session of radiation treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiosurgery (SSRS) | Procedure | Target dose of 18 or 24 Gy to spine in single session of radiation treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Occurrences of Paralysis caused by Radiation Myelitis (RM) | Incidence of patients who are ambulatory at baseline, 3 months and 6 months will be tabulated. Cases of patients who develop spinal cord myelopathy determined to be radiation related graded according to NCI CTC v4.0 scale. | Up to 12 months following radiation |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amol J. Ghia, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
Not provided
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided