Status:
ACTIVE_NOT_RECRUITING
Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation
Lead Sponsor:
Baptist Health South Florida
Collaborating Sponsors:
Medtronic
Conditions:
Oncology
Spine Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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'...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2027
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04375891
Start Date
May 22 2020
End Date
July 1 2027
Last Update
February 4 2025
Active Locations (1)
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1
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, United States, 33176