NCT04375891

Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation

Randomized Phase II Study of Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation for Localized Spine Metastasis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Baptist Health South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The spread of cancer to the spine is referred to as spine metastasis. Spine metastases are a common complication of cancer and are frequently associated with significant back pain. This study is being done to help improve treatment for back pain caused by spinal metastases by comparing the effectiveness of two standard treatments. These two treatments include radiation therapy (RT) alone versus radiation therapy combined with radiofrequency ablation, with or without vertebral augmentation (PVA/RFA). In addition to RT or RT with PVA/RFA, will be continued with current pain medications.

Detailed description

All supportive therapy for optimal medical care will be given during the study period at the discretion of the attending physician(s) within the parameters of the protocol and documented on each site's source documents as concomitant medication. The study will be adequately powered with 52 patients (35 in the RT plus PVA/RFA arm and 17 in the RT arm). Assuming a 5% ineligibility rate, a death rate of 15%, and a patient non-compliance rate of 15%, the total sample size required would be 80 patients. Patients will be stratified according to the tumor type (radioresistant \[soft tissue sarcoma, melanoma, and renal cell carcinoma\] versus other types). The treatment allocation scheme described by Zelen (1974) will be used because it balances patient factors. Within each stratum, patients will be randomized in a 2:1 ratio to either image-guided RT plus RFA/PVA or external beam RT alone. The 2:1 randomization allocation will be used to accommodate increased demand for image-guided RT plus RFA/PVA.

Conditions

• Oncology
• Spine Metastases

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	30 Gy in 10 fractions of 3 Gy each
RADIATION	Radiofrequency Ablation (RFA)	Radiofrequency Ablation (RFA) / Vertebral Augmentation

Timeline

• Start date: 2020-05-22
• Primary completion: 2025-10-01
• Completion: 2027-07-01
• First posted: 2020-05-06
• Last updated: 2025-02-04

Locations

1 site across 1 country: United States