Spine Radiosurgery for Symptomatic Metastatic Neoplasms

The purpose of this study is to compare three types of radiation therapy for cancer that has spread to the spine. The two types of radiation therapy used in this trial are External Beam Radiation Therapy (EBRT) and Stereotactic Body Radiation Therapy (SBRT). EBRT delivers tightly targeted radiation beams from outside the body. SBRT is a specialized type of radiation therapy that allows high doses of radiation to small targets. This study will include standard dose SBRT and higher dose SBRT. Each participant will be randomly assigned to either EBRT, standard dose SBRT, or higher dose SBRT.

Inclusion Criteria:Participant must have histologic confirmation of malignancy. Spinal metastatic disease must be confirmed by imaging.Participant must have received no prior therapies for this disease. Prior therapy includes previous radiation therapy encompassing the anatomic site to be treated with spine SBRTAge >18 years. This study requires informed consent by the participant; as children are not able to perform this without parental approval, Participant < age 18 are excluded from this study.Life expectancy of≥ 3 months, in the opinion of and as documented by the investigator.Participant must have a worst pain score ≥ 2 of 10 according to the Brief Pain InventoryParticipant must have no intention of changing pain medications on the first day of SBRTParticipant must have a Spinal Instability score (SINS) ≤ 12Participant must have no systemic chemotherapy at least 1 week before or after SBRTParticipant must have no non-cytotoxic systemic therapy (excluding endocrine therapy delivered within 24 hours before or after completion of SBRT)Participant must be a spine SBRT candidate per Radiation OncologyParticipant must have the ability to understand and the willingness to sign a written informed consent documentExclusion Criteria:Prior treatment toxicities resolved to < Grade 5 according to NCI CTCAE Version 4.0 (list exceptions, e.g. alopecia, neuropathy, etc)Participant receiving any other investigational agents.Participant with prognosis less than 3 months will be excluded from this clinical trial because of their poor prognosis and decreased likelihood to meet the primary endpointParticipant with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.Pregnant or nursing Participant are excluded due to toxicity of radiation therapy.Participant is unable to receive MRI of the spineParticipant has a Spinal Instability in Neoplasia score (SINS) ≥ 12Participant has received previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment fieldParticipant has more than 3 consecutive vertebral bodies in the SBRT treatment volumeParticipant is not an SBRT candidate per radiation oncology discretionParticipant has a known primary and has an estimated median survival≤ 3 months per ds-GPAParticipant has an unknown primaryParticipant has a Brief Pain Inventory score > 2Participant has received previous radiation therapy involving the intended SBRT treatment fieldParticipant has received previous spinal surgical procedure involving the SBRT target volumeParticipant has neurological deficits from malignant cauda equina compression or epidural spinal cord compression