Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone
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
- Spine Metastases
- Bone Pain
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
| Arm | Description | Assigned 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 |
|
|
Placebo Comparator Radiotherapy alone |
ONLY uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size |
|
Recruiting Locations
University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55455
Minneapolis 5037649, Minnesota 5037779 55455
More Details
- Status
- Recruiting
- Sponsor
- University of Minnesota