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NCT Number: NCT07090122

Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

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.

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Key information

Conditions

Spine Metastases Bone Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Deb Mailand

CONTACT

[email protected]

612-626-2498

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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

Treatment and study plan

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

  1. Skeletal-related event (SREs) outcomes at 1 month

    Time frame: 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.

  2. Skeletal-related event (SREs) outcomes at 3 months

    Time frame: 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.

  3. Skeletal-related event (SREs) outcomes at 6 months

    Time frame: 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.

  4. Skeletal-related event (SREs) outcomes at 12 months

    Time frame: 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.

  5. Skeletal-related event (SREs) outcomes at 24 months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Surgery Clinical Trials Office

CONTACT

[email protected]

612-624-7463

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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