Case Comprehensive Cancer Center
Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue. One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.
The primary objective of this study is to establish the non-inferiority in vertebral compression fracture (VCF) incidence at 6 months between single-fraction and two-fraction sSRS. Other objectives are to to evaluate the 12-month impact of single- and two-fraction sSRS on local control (LC), pain control (PC), quality of life (QOL), and toxicity (specifically, pain flare, radiation esophagitis/laryngitis/pharyngitis, and radiation myelitis) This study is planned as a two-arm randomized phase II trial to establish non-inferiority of single fraction sSRS compared to two-fraction sSRS. Approxim…
Inclusion Criteria: * Karnofsky Performance Status (KPS) ≥ 70 * 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) * Vertebral metastases from C3 to L5 based on bone scan, CT, PET, or MRI. * Vertebral metastases must be (1) solitary, (2) at two contiguous levels, or (3) a maximum of three separate sites, with a maximum of two contiguous levels. * Radioresistant metastases are permitted (including sarcomas, melanomas, and renal cell carcinomas). * Patients with epidural…
Diagnostic MRI
Planning MRI: high definition (HD) MRI of the region of interest (1 vertebral level above and below the level(s) being treated)
Simulation CT is obtained (1.5 mm slice thickness)
QOL assessment
Brief pain inventory (BPI), including narcotic assessment
sSRS 18 Gy in 1 fraction
sSRS 24 Gy in 2 fractions to be delivered either on consecutive days or one day apart.
Arctuva estimate
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