Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

• Radiofrequency ablation and bone augmentation with radiotherapy (Procedure): employs radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent
• Radiotherapy alone (Procedure): High-energy radiation

Primary outcomes

• Skeletal-related event (SREs) outcomes at 1 month [Month 1]: Skeletal-related events are defined as new clinical or radiologic evidence of pathologic fracture, spinal cord or nerve root compression, pain or instability, and/or necessity for additional local intervention (i.e. surgery, repeat RFA/BA or RT) due to persistent or progressive symptoms.
• Skeletal-related event (SREs) outcomes at 3 months [Month 3]: Skeletal-related events are defined as new clinical or radiologic evidence of pathologic fracture, spinal cord or nerve root compression, pain or instability, and/or necessity for additional local intervention (i.e. surgery, repeat RFA/BA or RT) due to persistent or progressive symptoms.
• Skeletal-related event (SREs) outcomes at 6 months [Month 6]: Skeletal-related events are defined as new clinical or radiologic evidence of pathologic fracture, spinal cord or nerve root compression, pain or instability, and/or necessity for additional local intervention (i.e. surgery, repeat RFA/BA or RT) due to persistent or progressive symptoms.
• Skeletal-related event (SREs) outcomes at 12 months [Month 12]: Skeletal-related events are defined as new clinical or radiologic evidence of pathologic fracture, spinal cord or nerve root compression, pain or instability, and/or necessity for additional local intervention (i.e. surgery, repeat RFA/BA or RT) due to persistent or progressive symptoms.
• Skeletal-related event (SREs) outcomes at 24 months [Month 24]: Skeletal-related events are defined as new clinical or radiologic evidence of pathologic fracture, spinal cord or nerve root compression, pain or instability, and/or necessity for additional local intervention (i.e. surgery, repeat RFA/BA or RT) due to persistent or progressive symptoms.

Sex: All, ages: 18 Years to any

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

• Reza Talaie, Principal investigator, University of Minnesota