Radiofrequency ablation and bone augmentation plus radiotherapy vs radiotherapy alone for spinal metastases

Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

This trial will test whether adding radiofrequency ablation and bone augmentation to radiotherapy helps people with metastatic spine disease (T5-L5) have fewer skeletal-related events and less pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Minnesota (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT07090122 on ClinicalTrials.gov

What this trial studies

This single-center, randomized pilot trial at the University of Minnesota randomizes patients 2:1 to receive one session of radiofrequency ablation with bone augmentation plus radiotherapy or radiotherapy alone for metastatic disease of the T5-L5 spine (up to two levels). The study tracks skeletal-related events—including pathologic fracture, spinal cord or nerve root compression, instability, persistent pain, or need for additional local interventions—over 24 months with assessments at 1, 3, 6, 12, and 24 months. Eligibility requires histologically confirmed spinal metastasis with pain or imaging predictors of SRE and adequate organ function. The primary aim is to compare the occurrence of SREs between the combined RFA/BA+RT arm and the RT-only arm in this pilot setting.

Who should consider this trial

Good fit: Adults 18 or older with histologically confirmed metastatic disease involving T5–L5 (up to two levels), who have bone pain or imaging features predicting skeletal-related events and meet required laboratory criteria are the ideal candidates.

Not a fit: Patients without metastatic spine disease, with more extensive multi-level or unstable spinal disease requiring immediate surgery, or those who do not meet the laboratory or organ function criteria are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, adding RFA and bone augmentation to radiotherapy could lower the risk of fractures and nerve compression, reduce the need for further local procedures, and improve pain control.

How similar studies have performed: Nonrandomized series and small trials have shown that RFA and vertebral augmentation can reduce pain and stabilize metastatic vertebrae, but randomized evidence combining RFA/BA with radiotherapy specifically to prevent SREs is limited.

Eligibility criteria

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

Where this trial is running

Minneapolis, Minnesota

• University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Reza Talaie — University of Minnesota
• Study coordinator: Surgery Clinical Trials Office

Conditions Spine Metastases; Bone Pain; Radiofrequency ablation; Bone augmentation; Radiotherapy; Metastatic disease of the spine