Active — Not RecruitingPhase 1

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)

United States43 participantsStarted 2010-12-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

Exclusion criteria

✕. 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
✕. 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

What they're measuring

Number of Occurrences of Paralysis caused by Radiation Myelitis (RM)

Timeframe: Up to 12 months following radiation

Trial details

NCT IDNCT01254903

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04-01

View on ClinicalTrials.gov More Metastatic Epidural Spinal Cord Compression trials