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)
Running, not enrolling · Phase 1
Conditions studied: Metastatic Epidural Spinal Cord Compression
In brief
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.
Key facts
- Study ID
- NCT01254903
- Run by
- M.D. Anderson Cancer Center
- People needed
- 43
- Starts
- 2010-12-03
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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