Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Lesions at C1-2 or S1-Coccyx.
Hematologic malignancies including lymphoma and myeloma.
Multiple primary cancers.
Primary neoplasms of the spine
Trial design
Treatments tested in this trial
- Diagnostic MRI
- Planning MRI
- Simulation CT
- QOL assessment
- Brief pain inventory (BPI)
- sSRS in 1 fraction
- sSRS in 2 fraction
Treatment groups
130 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov