Single Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01256554
First received: December 7, 2010
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Metastatic Epidural Spinal Cord Compression
Procedure: Stereotactic Radiosurgery (SSRS)
Behavioral: Questionnaires
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Occurrences of Paralysis Caused by Radiation Myelitis (RM) [ Time Frame: Up to 12 months following radiation ] [ Designated as safety issue: Yes ]
    Maximum acceptable Dmax will be that in which there are fewer RM events than TP events prior to 12 months and less than 2 RM events.


Estimated Enrollment: 36
Study Start Date: December 2010
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic Radiosurgery (SSRS)
Target dose of 18 or 24 Gy to spine in single session of radiation. Questionnaire completion about health symptoms and pain at baseline, 3 months, 6 months, 9 months, 12 months, 24 months, then every 6 months.
Procedure: Stereotactic Radiosurgery (SSRS)
Target dose of 18 or 24 Gy to spine in single session of radiation.
Other Names:
  • Stereotactic Radiosurgery
  • SSRS
  • Radiation
  • Radiotherapy
  • Metastatic Epidural Spinal Cord Compression
  • MESCC
Behavioral: Questionnaires
Questionnaire completion about health symptoms and pain at baseline, 3 months, 6 months, 9 months, 12 months, 24 months, then every 6 months.
Other Name: Surveys

Detailed Description:

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 MD Anderson.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 </= 3 months prior to registration
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256554

Contacts
Contact: Amol J. Ghia, MD 713-563-2300

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Amol J. Ghia, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01256554     History of Changes
Other Study ID Numbers: 2010-0653, NCI-2011-00273
Study First Received: December 7, 2010
Last Updated: September 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Stereotactic Radiosurgery
SSRS
Radiation
Radiotherapy
Metastatic Epidural Spinal Cord Compression
MESCC

Additional relevant MeSH terms:
Spinal Cord Compression
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Spinal Cord Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 22, 2014