%0 Journal Article
%@ 1471-2407
%A Bludau, Frederic
%A Welzel, Grit
%A Reis, Tina
%A Abo-Madyan, Yasser
%A Sperk, Elena
%A Schneider, Frank
%A Clausen, Sven
%A Ruder, Arne M.
%A Obertacke, Udo
%A Ghaly, Maged M.
%A Wenz, Frederik
%A Giordano, Frank A.
%C London ; Berlin , Heidelberg
%D 2019
%F heidok:26417
%I BioMed Central ; Springer
%J BMC Cancer
%K Kypho-IORT, Intraoperative radiotherapy, Kyphoplasty, Cement augmentation, Vertebral metastases, External beam radiotherapy
%N 430
%P 1-7
%T Combined kyphoplasty and intraoperative radiotherapy (Kypho-IORT) versus external beam radiotherapy (EBRT) for painful vertebral metastases - a randomized phase III study
%U https://archiv.ub.uni-heidelberg.de/volltextserver/26417/
%V 19
%X Background: The spine is the most frequent location of bone metastases. Local treatment aims at palliation of pain and, given the increased likelihood of long-term cancer survival, at local control. Kyphoplasty and intraoperative radiotherapy (Kypho-IORT) provided instantaneous pain relief in 70% of patients at the first day after the intervention and resulted in local control rates of > 93% at 1 year in a recently conducted phase I/II trial. To assess its clinical value, we designed a phase III trial which tests Kypho-IORT against the most widespread standard-of-care, external beam radiotherapy (EBRT), in patients with painful vertebral metastases.    Methods: This phase III study includes patients ≥50 years of age with up to 4 vertebral metastases and a pain score of at least 3/10 points on the visual/numeric analogy scale (VAS). Patients randomized into the experimental arm (A) will undergo Kypho-IORT (Kyphoplasty plus IORT with 8 Gy prescribed to 13 mm depth). Patients randomized into the control arm (B) will receive EBRT with either 30 Gy in 10 fractions or 8 Gy as a single dose. The primary end point is pain reduction defined as at least − 3 points on the VAS compared to baseline at day 1. Assuming that 40% of patients in the Kypho-IORT arm and 5% of patients in the control arm will achieve this reduction and 20% will drop out, a total of 54 patients will have to be included to reach a power of 0.817 with a two-sided alpha of 0.05. Secondary endpoints are evaluation of the percentage of patients with a pain reduction of at least 3 points at 2 and 6 weeks, local tumor control, frequency of re-intervention, secondary fractures/sintering, complication rates, skin toxicity/wound healing, progression-free survival (PFS), overall survival (OS) and quality of life.       Discussion: This trial will generate level 1 evidence on the clinical value of a one-stop procedure which may provide instantaneous pain relief, long-term control and shortened intervals to further adjuvant (systemic) therapies in patients with spinal metastases.       Trial registration Registered with ClinicalTrials.gov, number: NCT02773966. Registration date: 05/16/2016.