Stereotactic Radiotherapy Followed by Surgical Stabilization Within 24 h for Unstable Spinal Metastases; A Stage I/IIa Study According to the IDEAL Framework

Abstract

Background: Routine treatment for unstable spinal metastases consists of surgical stabilization followed by external beam radiotherapy (EBRT) or stereotactic body radiotherapy (SBRT) after a minimum of 1–2 weeks to allow for initial wound healing. Although routine treatment, there are several downsides. First, radiotherapy induced pain relief is delayed by the time interval required for wound healing. Second, EBRT often requires multiple hospital visits and only 60% of the patients experience pain relief. Third, spinal implants cause imaging artifacts hindering SBRT treatment planning and delivery. Reversing the order of surgery and radiotherapy, with dose sparing of the surgical area by SBRT, could overcome these disadvantages and by eliminating the interval between the two treatments, recovery, and palliation may occur earlier.Design: The safety of SBRT followed by surgical stabilization within 24 h for the treatment of unstable spinal metastases was investigated. Safety was evaluated using the Common-Toxicity-Criteria-Adverse-Events-4.0, with the occurrence of wound complications within 90-days being the primary concern.Results: Between June-2015 and January-2017, 13 patients underwent SBRT followed by surgical stabilization for unstable spinal metastases. The median time between SBRT and surgery was 17-h (IQR 5–19). None of the patients experienced wound complications. Improvements in pain and quality of life were observed over time for all patients.Conclusion: SBRT followed by surgical stabilization within 24 h for the treatment of unstable spinal metastases is safe. Palliation may be experienced earlier and with both treatments being performed in one hospital admission the treatment burden decreases.

Outcome selection, measurement and reporting for new surgical procedures and devices: a systematic review of IDEAL/IDEAL-D studies to inform development of a core outcome set

“…Initial screening identified 62 of 136 records (45·6 per cent) for full‐text eligibility assessment. Finally, 48 relevant publications (42 study reports, 6 protocols) were included in the analysis 24–71 ( Fig . 1 ).…”

The IDEAL framework in neurosurgery: a bibliometric analysis

“…Following deduplication and abstract review, 51 relevant articles were identified. Thereafter remained fourteen primary papers [8,17,20,26,33,34,37,39,46,51,55,[58][59][60], and 37 secondary papers [1-5, 9-12, 14-16, 23, 27, 29-32, 35, 36, 38, 40, 43-45, 47-50, 52-54, 57, 62, 64-66].…”

Photodynamic Therapy for the Treatment of Vertebral Metastases: A Phase I Clinical Trial

“…Local tumor progression was noted in 9 of the 30 patients. The median time from PDT to tumor progression was 2.5 months (range, [1][2][3][4][5][6][7][8][9][10][11][12]. Two of the patients with local progression (50 J/cm group) had never received RT at the site of intervention and, therefore, were classified as having local mechanical failure due to VCA but not to RT.…”

“…However, these thermal techniques are limited by the proximity of lesions to the spinal canal and neurologic structures. The current clinical paradigm combines RT (including SBRT) with VCA and is effective at addressing both instability and tumor growth (8,9). Future treatment paradigms, however, may lie in applying novel local nonionizing therapies at the time of VCA.…”