Spine Radiosurgery for Symptomatic Metastatic Neoplasms
Metastatic Neoplasm to the Spine, Metastatic Neoplasm
About this trial
This is an interventional treatment trial for Metastatic Neoplasm to the Spine focused on measuring Radiosurgery, External Beam Radiation Therapy, Stereotactic Body Radiation Therapy, Spine Stereotactic Radiosurgery, SPORTSMEN
Eligibility Criteria
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 SBRT. This includes any previous radiation therapy where the treatment field overlaps with the anatomic site to be treated with spine SBRT (even if that previous radiation therapy was not for treatment of spinal disease). Systemic radiation therapy for metastatic disease such as Pluvicto also counts as previous radiation therapy. Age >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 Inventory Participant must have no intention of changing pain medications on the first day of SBRT Participant must have a Spinal Instability score (SINS) ≤ 12 Participant must be a spine SBRT candidate per Radiation Oncology Participant must have the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 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 endpoint Participant 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 spine Participant has a Spinal Instability in Neoplasia score (SINS) ≥ 12 Participant has received previous stereotactic radiosurgery where the 50% isodose line overlaps with current treatment field Participant has more than 3 consecutive vertebral bodies in the SBRT treatment volume Participant is not an SBRT candidate per radiation oncology discretion Participant has a known primary and has an estimated median survival≤ 3 months Participant has an unknown primary Participant has a Brief Pain Inventory score > 2 Participant has received previous radiation therapy involving the intended SBRT treatment field Participant has received previous spinal surgical procedure involving the SBRT target volume. Biopsy is not considered a previous spinal surgical procedure. Participant has neurological deficits from malignant cauda equina compression or epidural spinal cord compression
Sites / Locations
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Standard dose SBRT
High dose SBRT
Conventional EBRT
Participants will undergo standard dose Stereotactic Body Radiation Therapy
Participants will undergo high dose Stereotactic Body Radiation Therapy
Participants will undergo External Beam Radiation Therapy