Phase II/III Study of Image-Guided Radiosurgery/SBRT for Localized Spine Metastasis

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Diagnosis of localized spine metastasis at the C1 to L5 levels by a screening imaging
study (bone scan, PET, CT, or MRI), meeting any of the following criteria:

- Solitary spine metastasis

- Two contiguous spine levels involved

- No more than 3 separate sites (e.g., C5, T5-6, and T12) involved

- No more than 2 contiguous vertebral bodies involved at each separate site

- Other visceral metastasis, and radioresistant tumors (including soft tissue
sarcomas, melanomas, and renal cell carcinomas) are eligible

- No myeloma or lymphoma

- Epidural compression allowed provided there is ≥ 3 mm gap between the spinal cord and
edge of epidural lesion

- Paraspinal mass allowed provided it is ≤ 5 cm in the greatest dimension and
contiguous with spine metastasis

- Has undergone MRI of the involved spine within the past 4 weeks to determine the
extent of spine involvement

- No spine metastasis that is not planned to be treated per protocol

- No rapid neurologic decline

- Mild to moderate neurological signs, including radiculopathy, dermatomal sensory
change, and muscle strength of involved extremity 4/5 (lower extremity for
ambulation or upper extremity for raising arms and/or arm function), allowed

- No spine instability due to compression fracture, frank spinal cord compression or
displacement, or epidural compression within 3 mm of the spinal cord

- No more than 50% loss of vertebral body height

- No bony retropulsion causing neurologic abnormality

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Negative pregnancy test

- Fertile patients must use effective contraception

- Must be ambulatory

- No medical contraindications to an MRI of the spine

- No allergy to contrast dye used in MRI or CT scans

- The patient must have a score on the Numerical Rating Pain Scale of ≥ 5 within 1 week
prior to registration for at least one of the planned sites for spine radiosurgery

- Documentation of the patient's initial pain score is required

- Patients taking medication for pain at the time of registration are eligible

PRIOR CONCURRENT THERAPY:

- Concurrent pain medication allowed

- No prior radiotherapy to the index spine

- No chemotherapy for ≥ 24 hours before, during, and for ≥ 24 hours after completion of
radiosurgery