Single Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression
NCT ID: NCT01256554
Last Updated: 2021-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
11 participants
INTERVENTIONAL
2010-12-03
2021-10-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Stereotactic Radiosurgery (SSRS)
Target dose of 18 or 24 Gy to spine in single session of radiation.
Questionnaires
Questionnaire completion about health symptoms and pain at baseline, 3 months, 6 months, 9 months, 12 months, 24 months, then every 6 months.
Interventions
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Stereotactic Radiosurgery (SSRS)
Target dose of 18 or 24 Gy to spine in single session of radiation.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Amol J. Ghia, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2011-00273
Identifier Type: REGISTRY
Identifier Source: secondary_id
2010-0653
Identifier Type: -
Identifier Source: org_study_id