Combined kyphoplasty and intraoperative radiotherapy (Kypho-IORT) versus external beam radiotherapy (EBRT) for painful vertebral metastases - a randomized phase III study.

ABSTRACT:

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

SUBMITTER: Bludau F 

PROVIDER: S-EPMC6507138 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature