Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery

PRIMARY OBJECTIVES:

I. To assess the feasibility of single-fraction radiotherapy to provide a short-interval
treatment response in patients with metastatic epidural spinal cord compression (MESCC),
such that additional stereotactic radiotherapy to full therapeutic doses can be delivered
while respecting spinal cord constraints, based on the following metrics: shortest distance
between gross disease and the spinal cord before and after treatment; epidural tumor volume
before and after treatment; and extent of epidural compression before and after treatment.

SECONDARY OBJECTIVES:

I. To evaluate pain control using the Numerical Rating Pain Scale (NRPS) before and after
treatment.

II. To evaluate patient quality of life using the Functional Assessment of Cancer
Therapy-General (FACT-G) before and after treatment.

III. To evaluate functional outcomes using ambulation score and standardized neurologic
exams before and after treatment.

OUTLINE:

Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second
treatment of adaptive staged SBRT at the discretion of the treating physician based on
clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose
constraints.

After completion of study treatment, patients are followed up periodically.

Inclusion Criteria:

- Localized spine metastasis from the cervical (C)1 to lumbar (L)5 levels with
documented epidural cord compression by a screening imaging study (magnetic resonance
imaging [MRI] or computed tomography [CT] myelogram); site may have a maximal
involvement of 2 contiguous vertebral bodies; patients with other visceral
metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and
renal cell carcinomas) are eligible

- History/physical examination by the treating physician within 24 hours prior to
registration

- Neurological and functional examination within 24 hours prior to registration by the
treating physician

- Negative serum pregnancy test

- MRI (contrast is not required but strongly recommended) or CT myelogram of the
involved spine within 1 week prior to registration to determine the extent of the
spine involvement

- Numerical rating pain scale within 1 week prior to registration; documentation of the
patient's initial pain score is required; patients taking medication for pain at the
time of registration are eligible

- Women of childbearing potential must:

- Have a negative serum or urine pregnancy test within 72 hours prior to the start
of study therapy

- Agree to utilize an adequate method of contraception throughout treatment and
for at least 4 weeks after study therapy is completed

- Be advised of the importance of avoiding pregnancy during trial participation
and the potential risks of an unintentional pregnancy

- All patients must sign study specific informed consent prior to study entry or within
1 week of first treatment, provided other criteria were met

- Patients considered for enrollment are strongly recommended to have been discussed at
multidisciplinary tumor board with input from surgery, medical oncology and radiation
oncology prior to enrollment

Exclusion Criteria:

- Histologies of myeloma or lymphoma

- Cord compression at 2 non-contiguous sites in the spine

- Favorable candidates for surgical decompression by prior documented criteria

- Spine instability as determined by Spinal Instability Neoplastic Score (SINS) score >
12

- > 50% loss of vertebral body height

- Bony retropulsion causing neurologic abnormality

- Prior radiation to the index spine

- Patients who cannot obtain a contrast-enhanced MRI or CT myelogram due to allergy,
renal failure or other medical contraindication