RFA/BA & RTRadiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

Inclusion Criteria:

• Histologically confirmed metastatic T5-L5 disease of the spine (with up to two levels) as detected by any imaging study.
• Have either associated bone pain or cross-sectional imaging characteristics that are predictors of SRE.
• Age 18 years of age or older at the time of consent.
• Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to study enrollment defined as:

1. absolute neutrophil count (ANC) ≥ 1.5 × 109/L
2. platelets ≥ 50 × 109/L
3. hemoglobin ≥ 10 g/dL, independent of transfusion ≤14 days of screening
4. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN
5. total bilirubin ≤ 1.5 × ULN; < 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome
6. serum albumin ≥ 30 g/L (3.0 g/dL)
7. serum creatinine ≤ 1.5 x ULN; OR estimated glomerular filtration rate (GFR) ≥ 45 mL/min using the Cockcroft Gault formula

• Persons of childbearing potential (POCB) or with partners of childbearing potential must be willing to use contraception during study treatment and 6 months after study treatment.
• Persons are considered to be of childbearing potential unless one or the following applies:

1. Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause
2. Considered permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy

• Voluntary written consent prior to the performance of any research related activity

Exclusion Criteria:

• Pregnant or breastfeeding.
• Clinical or radiologic evidence of epidural spinal cord compression or radicular pain.
• Prior radiation therapy to the target lesion.
• Candidates for spine stabilization surgery.
• The target lesion(s) is deemed ineligible for RFA/BA (e.g. unstable existing fractures/impending fractures, involvement of the posterior elements, retropulsion, spinal canal narrowing, neuroforaminal narrowing, uncontrolled bleeding diathesis, active infection anywhere in the body, or purely blastic tumor). Note: Mixed lytic/blastic tumors are eligible.
• The target lesion(s) size or location is beyond RFAs ability to safely perform, at the physician's discretion