Spine Metastases, Bone Pain
Conditions
Keywords
Radiofrequency ablation (RFA), Bone augmentation (BA), Radiotherapy (RT), Metastatic disease of the spine
Brief 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.
Interventions
PROCEDURERadiofrequency ablation and bone augmentation with radiotherapy
employs radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent
PROCEDURERadiotherapy alone
High-energy radiation
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single-center, randomized 2 arm controlled pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skeletal-related event (SREs) outcomes at 1 month | 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. |
| Skeletal-related event (SREs) outcomes at 3 months | 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. |
| Skeletal-related event (SREs) outcomes at 6 months | 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. |
| Skeletal-related event (SREs) outcomes at 12 months | 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. |
| Skeletal-related event (SREs) outcomes at 24 months | 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. |
Countries
United States
Contacts
Primary ContactSurgery Clinical Trials Office
Outcome results
None listed