title: Combined kyphoplasty and intraoperative radiotherapy (Kypho-IORT) versus external beam radiotherapy (EBRT) for painful vertebral metastases - a randomized phase III study
creator: Bludau, Frederic
creator: Welzel, Grit
creator: Reis, Tina
creator: Abo-Madyan, Yasser
creator: Sperk, Elena
creator: Schneider, Frank
creator: Clausen, Sven
creator: Ruder, Arne M.
creator: Obertacke, Udo
creator: Ghaly, Maged M.
creator: Wenz, Frederik
creator: Giordano, Frank A.
subject: ddc-610
subject: 610 Medical sciences Medicine
description: 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.
publisher: BioMed Central ; Springer
date: 2019
type: Article
type: info:eu-repo/semantics/article
type: NonPeerReviewed
format: application/pdf
identifier: https://archiv.ub.uni-heidelberg.de/volltextserverhttps://archiv.ub.uni-heidelberg.de/volltextserver/26417/1/12885_2019_Article_5666.pdf
identifier: DOI:
identifier: urn:nbn:de:bsz:16-heidok-264172
identifier:   Bludau, Frederic ; Welzel, Grit ; Reis, Tina ; Abo-Madyan, Yasser ; Sperk, Elena ; Schneider, Frank ; Clausen, Sven ; Ruder, Arne M. ; Obertacke, Udo ; Ghaly, Maged M. ; Wenz, Frederik ; Giordano, Frank A.  (2019) Combined kyphoplasty and intraoperative radiotherapy (Kypho-IORT) versus external beam radiotherapy (EBRT) for painful vertebral metastases - a randomized phase III study.  BMC Cancer, 19 (430).  pp. 1-7.  ISSN 1471-2407     
relation: https://archiv.ub.uni-heidelberg.de/volltextserver/26417/
rights: info:eu-repo/semantics/openAccess
rights: Please see front page of the work (Sorry, Dublin Core plugin does not recognise license id)
language: eng