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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)


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Metastatic Epidural Spinal Cord Compression

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Trial Information

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
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 any use 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 (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.


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

5. Diagnosis of cancer (not one of the more radiosensitive histologies, see exclusion
criteria) 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 by patient refusal, by neurosurgical evaluation, or
for any reason

Exclusion Criteria:

1. Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell
carcinoma, germ cell tumors) as conventional radiation is likely to be effective

2. Prior irradiation of the spine site and level to be treated

3. Inability to tolerate lying flat on treatment table for greater than 30 minutes.

4. Patients unable to undergo MRI of the spine

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:

2010-0655

NCT ID:

NCT01254903

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Metastatic Epidural Spinal Cord Compression
  • Stereotactic Radiosurgery
  • Radiation
  • Radiotherapy
  • Metastatic Epidural Spinal Cord Compression
  • MESCC
  • Spinal Cord Compression

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030