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. 2016 Feb;71(2):101–109. doi: 10.6061/clinics/2016(02)09

Table 3.

Spine radiosurgery. Interventions and primary outcome descriptions from clinical trials registered at clinicaltrials.gov.

Study / Date started Status Design Condition Intervention Primary outcomes
NCT01654068 61 / Jul, 2012 Recruiting Phase II Spinal metastasis 1) 2-3 SM: 14 Gy SF2) 1 SM: 14 Gy SF Any skeletal-related event
NCT01223248 52 / Oct, 2012 Recruiting Phase III Spinal metastasis SR 24 Gy SF vs. SR, 27 Gy (HF) Loco-regional control rates
NCT01290562 62 / Jun 2011 Recruiting Phase II Spinal metastasis 20-24 Gy SF; or 20-24 Gy (HF)No prior RT or prior RT or Post-op Local control: image / symptoms
NCT00573872 63 / Dec 2007 Not recruiting (active) Phase I/II Spinal metastasis Phase 1: 20-25 Gy (HF) / Phase 2: 9-24 Gy (SF) TT: Safety
NCT01849510 64 / Apr 2013 Recruiting Phase II(2 arms) Spinal metastasis HF: 12×3 Gy+integrated boost 12×4 Gy / CRT 10×3 Gy Local control
NCT02167633 65 / Jul 2014 Recruiting Controlled (2 arms) MSCC Decompression surgery plus CRT / SR 16 Gy SF Ambulatory status
NCT00853528 66 / Feb 2009 Not recruiting (active) Phase I Spinal metastasis Maximum tolerated dose HF SR Dose escalation
NCT00631670 67 / Feb 2008 Completed Controlled Spinal metastasis 15 Gy SF / 25×2.8 Gy Safety
NCT01525745 68 / Jan 2012 Completed Phase II Spinal metastasis SR HF / CRT 10 fractions Pain control: NPRS
NCT01826058 69 / Apr 2013 Recruiting Phase II MSCC 16 -24 Gy SF / 21-36 HF Neurologic response
NCT01254903 70 / Dec 2012 Recruiting Phase I MSCC 18 Gy SF Safety
NCT00922974 9 / Nov 2009 Recruiting Phase II: completedPhase III Spinal metastasis SR 16 Gy SF / CRT 1×800 cGy Pain control
NCT01752036 71 / Mar 2013 Recruiting Phase II Spinal metastasis SR: 30 Gy (HF) Safety
NCT01347307 72 / Sep 2008 Not recruiting(active) Phase IV Spinal metastasis Benign: 12-16 Gy SF; 21-27 Gy HFMetastases: 14-25 Gy SF; 21-30 Gy HF Tumor control
NCT01231061 73 / Nov 2010 Completed Phase II Spinal metastasis Arm 1:SR 24 Gy HF / SR 16 Gy SF Pain control
NCT01950195 53 / Jun 2013 Recruiting Phase I Spinal metastasis SR+ipilimumab Safety
NCT01624220 74 / Jun 2012 Recruiting Assignment Spinal metastasis SR+4 gold seeds implanted Safety

SR: spine radiosurgery; NPRS: numeric pain rating scale; TT: tomotherapy; QA: quality assurance; SF: single fraction; HF: hypofractionated; CRT: conventional radiotherapy; Post Op.: post operative; MSCC: metastatic spinal cord compression.