Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Metastatic Epidural Spinal Cord Compression
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 compressio...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 3 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2027
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01254903
Start Date
December 3 2010
End Date
April 1 2027
Last Update
October 27 2025
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030