RecruitingNot ApplicableNCT07090122

Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

Sponsor

University of Minnesota

Enrollment

36 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Spine Metastases Bone Pain

Summary

This is a single-center, randomized controlled pilot study of radiofrequency ablation and bone augmentation (RFA/BA) plus radiotherapy (RT) vs. RT alone in patients with metastatic T5-L5 disease of the spine. Patients will be randomized 2:1 to receive either one treatment of RFA/BA plus RT or RT to evaluate the occurrence of skeletal-related events. Skeletal-related events (SREs) 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. Post-treatment follow-up for SREs are assessed at 1, 3, 6, 12, and 24 months.

Eligibility

Min Age: 18 Years

Inclusion Criteria16

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:
absolute neutrophil count (ANC) ≥ 1.5 × 109/L
platelets ≥ 50 × 109/L
hemoglobin ≥ 10 g/dL, independent of transfusion ≤14 days of screening
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN
total bilirubin ≤ 1.5 × ULN; \< 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome
serum albumin ≥ 30 g/L (3.0 g/dL)
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:
Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause
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 Criteria6

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

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