IRB Study Number 19-1275
Status Recruiting
Phase Phase 2
Location Cleveland Clinic Main Campus
Institute Taussig Cancer Institute
Description
Primary Objective
To establish the non-inferiority in VCF incidence at 6 months between single-fraction and two-fraction sSRS.
Secondary Objective(s)
To evaluate the 12-month impact of single- and two-fraction sSRS on:
Local control (LC)
Pain control (PC)
QOL
Toxicity: specifically, pain flare, radiation esophagitis/laryngitis/pharyngitis, and radiation myelitis.
Inclusion Criteria
4.1.1 Age ≥18
4.1.2 Karnofsky Performance Status (KPS) ≥ 70
4.1.3 RPA class 1 (KPS >70 AND controlled systemic disease) or RPA Class 2 (KPS >70, uncontrolled systemic disease OR KPS ≤70, age ≥54, no visceral metastases)44 (see Appendix II)
4.1.4 Vertebral metastases from C3 to L5 based on bone scan, CT, PET, or MRI. Patients with lesions at C1-C2 and S1-Coccyx either previously or concurrently treated are permitted, but only C3-L5 lesions may receive protocol treatment.
4.1.5 Vertebral metastases to be treated on study must be (1) solitary, (2) at two contiguous levels, or (3) a maximum of three separate sites, with a maximum of two contiguous levels.
4.1.6 Radioresistant metastases are permitted (including sarcomas, melanomas, and renal cell carcinomas).
4.1.7 Patients with epidural disease of index lesion(s) are permitted so long as there is no cord compression.
4.1.8 Paraspinal extension is permitted, so long as the paraspinal component of index lesion(s) is ≤5 cm
4.1.9 Multiple small metastatic lesions (<20% vertebral body involvement) of no clinical correlate are permitted, and not included in the irradiated segments as per RTOG 0631
4.1.10 History and physical within 60 days of registration. May be completed virtually.
4.1.11 Negative pregnancy test within 60 days of registration for women of childbearing potential.
4.1.12 Diagnostic spine MRI of interest within 60 days of registration
4.1.13 Neurological exam within 60 days of registration to rule out rapid neurological decline. Mild to moderate neurological deficits are acceptable, as long as distance between lesion and spinal cord is ≥3 mm
4.1.14 Patients may have prior EBRT at the index site.
4.1.15 Informed consent of the participant.
Exclusion Criteria
4.2.1 Age <18 years.
4.2.2 SRS of hematologic malignancies including lymphoma and multiple myeloma (patients with concurrent hematologic malignancies and multiple myeloma would otherwise be eligible).
4.2.3 Primary neoplasms of the spine
4.2.4 Prior corpectomy, kyphoplasty/vertebroplasty, or instrumentation at the site of planned sSRS.
4.2.5 Spinal cord compression due to metastasis within the area(s) to be treated.
4.2.6 Paraspinal mass of index lesion(s) >5 cm.
4.2.7 Patients with rapid neurologic decline.
4.2.8 Bony retropulsion of index lesion(s) resulting in neurologic deficit.
4.2.9 Patients with mechanical instability of the spine.
4.2.10 Patients with active connective tissue disease.
4.2.11 Patients who previously underwent sSRS to the vertebrae of interest.
4.2.12 Patients with diffuse or multilevel metastatic spinal disease with >20% involvement of vertebral bodies, defined as involvement of >5 vertebral levels.
4.2.13 Inability to participate in study activities due to physical or mental limitations.
4.2.14 Inability or unwillingness to return for all required follow-up visits and imaging.
4.2.15 Inability to deliver sSRS, either 18 Gy in one fraction, or 24 Gy in two fractions.
