Who is eligible for clinical trial NCT04375891?

Participants must meet protocol criteria for Oncology. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04375891 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2025-02-03

Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation (NCT04375891)

🔵 Active, Not Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Baptist Health South Florida

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (10 items).

Location: Miami Cancer Institute at Baptist Health South Florida — Miami, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

The patient must have localized spine metastasis from the T5 to L5 levels by an imaging study (bone scan, PET, CT, or MRI). Patients can have other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible.
Zubrod Performance Status 0-3
History/physical examination within 2 weeks prior to registration
Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential; Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control;
MRI (contrast is not required but strongly recommended) of the involved spine within 6 weeks prior to registration to determine the extent of the spine involvement;
Numerical Rating Pain Scale within 1 week prior to registration; the patient must have a score on the Scale of ≥ 5 for at least one of the planned sites for intervention. Documentation of the patient's initial pain score is required. Patients taking medication for pain at the time of registration are eligible.
Patients with epidural compression are eligible provided that there is a ≥ 3 mm gap between the spinal cord and the edge of the epidural lesion.
Patients must provide study specific informed consent prior to study entry.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Histologies of myeloma, lymphoma, small-cell lung cancer, germ-cell tumor
Non-ambulatory patients;
Frank spinal cord compression or displacement or epidural compression within 3 mm of the spinal cord;
Patients with rapid neurologic decline;
Bony retropulsion causing neurologic abnormality;
Prior radiation to the index spine
Patients requiring immediate neurosurgical intervention
Patients receiving concurrent chemotherapy
Patients needing palliative to more than 2 sites of spinal disease in total

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Miami Cancer Institute at Baptist Health South Florida — Miami, Florida

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗