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)
Primary Purpose
Metastatic Epidural Spinal Cord Compression
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Radiosurgery (SSRS)
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Epidural Spinal Cord Compression focused on measuring Stereotactic Radiosurgery, Radiation, Radiotherapy, Metastatic Epidural Spinal Cord Compression, MESCC
Eligibility Criteria
Inclusion Criteria:
- Greater than or equal to 18 years old
- 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.
- Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
- Signed Informed consent
- 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
- Motor Strength >/= 4 out of 5 in extremity or extremities affected by the level of the spinal cord compression
- Karnofsky performance status (KPS) >/= 40
- Patients deemed to be inoperable by patient refusal, by neurosurgical evaluation, or for any reason
Exclusion Criteria:
- Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors) as conventional radiation is likely to be effective
- Prior irradiation of the spine site and level to be treated
- Inability to tolerate lying flat on treatment table for greater than 30 minutes.
- Patients unable to undergo MRI of the spine
- Patients who are pregnant
- Patients who have cord compression from bone components or configuration
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stereotactic Radiosurgery (SSRS)
Arm Description
Target dose of 18 or 24 Gy to spine in single session of radiation treatment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01254903
First Posted
December 3, 2010
Last Updated
October 5, 2023
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01254903
Brief Title
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)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 3, 2010 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Epidural Spinal Cord Compression
Keywords
Stereotactic Radiosurgery, Radiation, Radiotherapy, Metastatic Epidural Spinal Cord Compression, MESCC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic Radiosurgery (SSRS)
Arm Type
Experimental
Arm Description
Target dose of 18 or 24 Gy to spine in single session of radiation treatment.
Intervention Type
Procedure
Intervention Name(s)
Stereotactic Radiosurgery (SSRS)
Other Intervention Name(s)
Radiotherapy, Radiation therapy
Intervention Description
Target dose of 18 or 24 Gy to spine in single session of radiation treatment.
Primary Outcome Measure Information:
Title
Number of Occurrences of Paralysis caused by Radiation Myelitis (RM)
Description
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.
Time Frame
Up to 12 months following radiation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Greater than or equal to 18 years old
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.
Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
Signed Informed consent
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
Motor Strength >/= 4 out of 5 in extremity or extremities affected by the level of the spinal cord compression
Karnofsky performance status (KPS) >/= 40
Patients deemed to be inoperable by patient refusal, by neurosurgical evaluation, or for any reason
Exclusion Criteria:
Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors) as conventional radiation is likely to be effective
Prior irradiation of the spine site and level to be treated
Inability to tolerate lying flat on treatment table for greater than 30 minutes.
Patients unable to undergo MRI of the spine
Patients who are pregnant
Patients who have cord compression from bone components or configuration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amol J. Ghia, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website
Learn more about this trial
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)
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