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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
single-center, randomized 2 arm controlled pilot study
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Radiofrequency ablation and bone augmentation with radiotherapy 		Radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent to offer both tumor control and structural reinforcement. Radiotherapy (RT) uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size
  • 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
Placebo Comparator
Radiotherapy alone 		ONLY uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size
  • Procedure: Radiotherapy alone
    High-energy radiation

Recruiting Locations

University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
Contact:
Deb Mailand
612-626-2498
mailand@umn.edu

More Details

Status
Recruiting
Sponsor
University of Minnesota

Study Contact

Surgery Clinical Trials Office
612-624-7463
surgCTO@umn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.