Single Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression (NCT01256554) | Clinical Trial Compass
CompletedPhase 1
Single Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression
United States11 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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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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
✕
What they're measuring
1
Number of Occurrences of Paralysis Caused by Radiation Myelitis (RM)
. 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