💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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