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Recruiting NCT07090122

Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

No phase Interventional Spine Metastases Bone Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiofrequency ablation and bone augmentation with radiotherapy, Radiotherapy alone.
Who it may be relevant to
Registry conditions: Spine Metastases, Bone Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • Skeletal-related event (SREs) outcomes at 1 month [Time frame: Month 1]
  • Skeletal-related event (SREs) outcomes at 3 months [Time frame: Month 3]
  • Skeletal-related event (SREs) outcomes at 6 months [Time frame: Month 6]
  • Skeletal-related event (SREs) outcomes at 12 months [Time frame: Month 12]
  • Skeletal-related event (SREs) outcomes at 24 months [Time frame: Month 24]

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:
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT07090122 · RAD-2023-32509

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗