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Phase I/II Evaluation of Single Session Stereotactic Body Radiotherapy for Spinal or Paraspinal Metastases

Phase 1/Phase 2
Open (Enrolling)
Spinal Neoplasms

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Trial Information

Phase I/II Evaluation of Single Session Stereotactic Body Radiotherapy for Spinal or Paraspinal Metastases

CT-on-Rails 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 before registration on this study. You will
also fill out a health survey, a symptom inventory, and a Brief Pain Inventory within 1 week
before registration. Each of these surveys should take about 5 minutes to complete. You
will have a CT-simulation. The simulation is like a CT scan where a special body frame is
used to keep you from moving during scanning and later radiation treatment. However, no
radiation is delivered during the simulation. You will be asked questions about your
medical history and have a complete neurological exam during your first consultation, before
registration. The neurological exam involves testing upper and lower motor strength,
sensation to light touch, reflexes, a mental exam, and an evaluation of the way you walk.

Radiation treatment will last between 2 and 2 1/2 hours and will be given on 1 day about 1
to 1 1/2 weeks after you had the simulation. You will have a device (similar to plastic
wrap) placed around you that will hold you still during the treatment. You will be checked
for level of pain and/or discomfort before starting each session of radiation, and you may
take pain medications before starting each session. All participants will be treated with
radiation therapy that is guided by the CT-on-Rails procedure. On the day of radiation, you
will also receive a CT scan using CT-on-Rails in the same treatment room, immediately before
the radiation treatment.

During treatment, a physician will be monitoring you for any side effects. If you
experience severe side effects, radiation treatment will be stopped, and you will be taken
off study. After treatment on this study ends, you will have telephone, mail, or facsimile
(Fax) follow-ups scheduled at 1, 2, 3, 4, and 8 weeks after radiation. You will be asked
questions about any side effects or pain you are experiencing and any other therapies you
may have started.

You will have follow-up visits scheduled at 3, 6, 9, 12, 18, and 24 months and then every 6
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 your neurologic function will be
evaluated. Any pain medication you are taking will be noted. You will be asked to have a
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, pain,
and quality of life at each follow-up visit. Each questionnaire should take around 5
minutes to complete.

This is an investigational study. The equipment used in this study are FDA-approved medical
devices and are commercially available. However, the way the devices are being used in this
study is experimental. Up to 60 patients will take part in this study. All will be enrolled
at M. D. Anderson.

Inclusion Criteria:

1. Radiographically documented spine or paraspinal metastasis demonstrated on spine MRI
within 4 weeks of registration

2. Maximum of 2 metastatic sites in the spine to be irradiated in single session

3. Informed consent for irradiation of spinal or para-spinal tumor (s)

4. Diagnosis of cancer including but not limited to lung (non-small cell and small
cell), breast, prostate, renal cell, melanoma, gastrointestinal, and germ cell
tumors, unknown primary tumors

5. Karnofsky performance status of at least 40 (ie not requiring active hospitalization)

Exclusion Criteria:

1. Worsening neurological status due to radiographic evidence of spinal cord compression
requiring immediate surgical decompression or emergent conventional external
radiation therapy.

2. Delay in initiation of radiation treatment would be potentially detrimental to
neurological outcome

3. Prior irradiation to current site of interest in the spine

4. Spinal metastasis in the cervical spine are not eligible for treatment

5. Unstable spine requiring surgical stabilization.

6. Sites outside the spine (eg. lung, liver) are not eligible for treatment

7. Patients currently receiving, or who have received chemotherapy within 30 days are
not eligible

8. Inability to tolerate lying flat on treatment couch for greater than 30 minutes.

9. Patient with multiple myeloma

10. Patients unable to undergo MRI of the spine

11. Patients with pacemakers

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and effectiveness of stereotactic body radiotherapy to the spine using computerized tomography (CT)-on-Rails in the treatment of metastatic spine tumors.

Outcome Time Frame:

5 Years

Safety Issue:


Principal Investigator

Paul Brown, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2005

Completion Date:

Related Keywords:

  • Spinal Neoplasms
  • Spinal Neoplasms
  • Paraspinal Metastases
  • Stereotactic Body Radiotherapy
  • CT-on-Rails
  • Spinal Cord
  • SBRT
  • Neoplasms
  • Spinal Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030