Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

University of Minnesota (UMN)

Status: Enrolling

Conditions: Bone Pain; Spine Metastases

Treatments: Procedure: Radiotherapy alone; Procedure: Radiofrequency ablation and bone augmentation with radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07090122

RAD-2023-32509

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups, including a placebo group

Radiofrequency ablation and bone augmentation with radiotherapy

Active Comparator group

Description:

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

Treatment:

Procedure: Radiofrequency ablation and bone augmentation with radiotherapy

Radiotherapy alone

Placebo Comparator group

Description:

ONLY uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size

Treatment:

Procedure: Radiotherapy alone