Single Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression
Primary Purpose
Metastatic Epidural Spinal Cord Compression
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Radiosurgery (SSRS)
Questionnaires
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Epidural Spinal Cord Compression focused on measuring Stereotactic Radiosurgery, SSRS, 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 for irradiation
- 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
- 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 due to patient refusal, by neurosurgical evaluation, or for any reason
- 1 prior course of spine radiotherapy to the current region of interest
Exclusion Criteria:
- Prior irradiation of the site to be treated </= 3 months prior to registration
- Inability to tolerate lying flat on treatment table for greater than 30 minutes.
- Patients unable to undergo MRI of the spine
- 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)
- 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. Questionnaire completion about health symptoms and pain at baseline, 3 months, 6 months, 9 months, 12 months, 24 months, then every 6 months.
Outcomes
Primary Outcome Measures
Number of Occurrences of Paralysis Caused by Radiation Myelitis (RM)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01256554
First Posted
December 7, 2010
Last Updated
October 21, 2021
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01256554
Brief Title
Single Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 3, 2010 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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 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.
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, SSRS, 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
11 (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. Questionnaire completion about health symptoms and pain at baseline, 3 months, 6 months, 9 months, 12 months, 24 months, then every 6 months.
Intervention Type
Procedure
Intervention Name(s)
Stereotactic Radiosurgery (SSRS)
Other Intervention Name(s)
Stereotactic Radiosurgery, SSRS, Radiation, Radiotherapy, Metastatic Epidural Spinal Cord Compression, MESCC
Intervention Description
Target dose of 18 or 24 Gy to spine in single session of radiation.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires
Other Intervention Name(s)
Surveys
Intervention Description
Questionnaire completion about health symptoms and pain at baseline, 3 months, 6 months, 9 months, 12 months, 24 months, then every 6 months.
Primary Outcome Measure Information:
Title
Number of Occurrences of Paralysis Caused by Radiation Myelitis (RM)
Description
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.
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 for irradiation
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
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 due to patient refusal, by neurosurgical evaluation, or for any reason
1 prior course of spine radiotherapy to the current region of interest
Exclusion Criteria:
Prior irradiation of the site to be treated </= 3 months prior to registration
Inability to tolerate lying flat on treatment table for greater than 30 minutes.
Patients unable to undergo MRI of the spine
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)
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
Single Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression
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