Phase I Study of Feasibility of Single Session Spine Stereotactic Radiosurgery (SSRS) in the Primary Management of Patients With Inoperable, Previously Irradiated Metastatic Epidural Spinal Cord Compression (MESCC)
18 Years
N/A
Both
Metastatic Epidural Spinal Cord Compression
Trial Information
Phase I Study of Feasibility of Single Session Spine Stereotactic Radiosurgery (SSRS) in the Primary Management of Patients With Inoperable, Previously Irradiated Metastatic Epidural Spinal Cord Compression (MESCC)
Spinal cord compression is often treated with surgery followed by radiation in small doses
every day 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:
- Your medical history will be recorded, including usage of steroids.
- You will have a neurological exam.
- You will complete the 3 questionnaires about health, symptoms you may be having, and
about pain.
- You will have an MRI of the spine.
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.
Inclusion Criteria:
1. Greater than or equal to 18 years old
2. Radiographically documented metastatic epidural compression on spine Magnetic
resonance imaging (MRI) within 4 weeks of registration, defined radiographically,
ranging from minimal canal compromise and thecal indentation to actual displacement
of the spinal cord.
3. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be
irradiated in a single session
4. Signed Informed consent for irradiation
5. Diagnosis of cancer including but not limited to non-small cell lung cancer, breast,
prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck
primary, and unknown primary tumors
6. Motor Strength >/= 4 out of 5 in extremity or extremities affected by the level of
the spinal cord compression
7. Karnofsky performance status (KPS) >/= 40
8. Patients deemed to be inoperable due to patient refusal, by neurosurgical evaluation,
or for any reason
9. 1 prior course of spine radiotherapy to the current region of interest
Exclusion Criteria:
1. Prior irradiation of the site to be treated
2. Inability to tolerate lying flat on treatment table for greater than 30 minutes.
3. Patients unable to undergo MRI of the spine
4. Patients who have previously received maximum cord tolerance of 45 Gy in 5 weeks
conventional fractionation or similar biologically effective dose (BED) to the area
of the spine to be treated. Below are the normalized BED at 2 Gy per fraction with
alpha/beta=2 for spinal cord in commonly used fractionation schemes in previously
irradiated patients. Conventional Radiotherapy (Normalized Biologically Effective
Dose) 20 Gy in 5 fractions(30 Gy 2/2), 30 Gy in 10 fractions(37.5 Gy 2/2), 37.5 Gy in
15 fractions(42 Gy 2/2), 40 Gy in 20 fractions(40 Gy 2/2), 45 Gy in 25 fractions(43
Gy 2/2), 50 Gy in 25 fractions(50 Gy 2/2) following equation: nBED is calculated by
dividing BED by (1 + d/a/b), where d is 2 Gy and for spinal cord late effect a/b is
2, and we describe the units as Gy 2/2 (i.e., Gy 2/2 = 2-Gy equivalent with a/b = 2)
5. Patients who are pregnant.
6. Patients who have cord compression from bone components or configuration.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Occurrences of Paralysis Caused by Radiation Myelitis (RM)
Outcome Time Frame:
Up to 12 months following radiation
Safety Issue:
Yes
Principal Investigator
Stephen Settle, MD,PHD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2010-0653
NCT ID:
NCT01256554
Start Date:
December 2010
Completion Date:
Related Keywords:
- Metastatic Epidural Spinal Cord Compression
- Stereotactic Radiosurgery
- SSRS
- Radiation
- Radiotherapy
- Metastatic Epidural Spinal Cord Compression
- MESCC
- Spinal Cord Compression
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
