Radiofrequency 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