About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

absolute neutrophil count (ANC) ≥ 1.5 × 109/L

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Radiofrequency ablation and bone augmentation with radiotherapy
Procedure/Surgery
employs radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent
Radiotherapy alone
Procedure/Surgery
High-energy radiation

Treatment groups

36 Participants

are divided into 2 treatment groups

Group A: Radiofrequency ablation and bone augmentation with radiotherapyActive comparator 1 intervention

Group B: Radiotherapy alonePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Skeletal-related event (SREs) outcomes at 1 month

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.

Time frame

Month 1

2

Skeletal-related event (SREs) outcomes at 3 months

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.

Time frame

Month 3

3

Skeletal-related event (SREs) outcomes at 6 months

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.

Time frame

Month 6

4

Skeletal-related event (SREs) outcomes at 12 months

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.

Time frame

Month 12

Radiofrequency Ablation/Bone Augmentation + Radiotherapy vs Radiotherapy Alone

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts