Ontology highlight
ABSTRACT: Background
Stereotactic body radiation therapy (SBRT)using intensity-modulated radiotherapy (IMRT) can be a safe modality for treating spinal bone metastasis with enhanced targeting accuracy and an effective method for achieving good tumor control and a rigorous pain response.Methods/design
This is a single-center, prospective randomized controlled trial to evaluate pain relief after RT and consists of two treatment groups with 30 patients in each group. One group will receive single-fraction intensity-modulated RT with 1 × 24 Gy, and the other will receive fractionated RT with 10 × 3 Gy. The target parameters will be measured at baseline and at 3 and 6 months after RT.Discussion
The aim of this study is to evaluate pain relief after RT in patients with spinal bone metastases by means of two different techniques: stereotactic body radiation therapy and fractionated RT. The primary endpoint is pain relief at the 3-month time-point after RT. Secondly, quality of life, fatigue, overall and bone survival, and local control will be assessed.Trial registration
ClinicalTrials.gov identifier NCT02358720 (June 2, 2015).
SUBMITTER: Rief H
PROVIDER: S-EPMC4465731 | biostudies-literature | 2015 Jun
REPOSITORIES: biostudies-literature
Rief Harald H Katayama Sonja S Bruckner Thomas T Rieken Stefan S Bostel Tilman T Förster Robert R Schlampp Ingmar I Wolf Robert R Debus Jürgen J Sterzing Florian F
Trials 20150609
<h4>Background</h4>Stereotactic body radiation therapy (SBRT)using intensity-modulated radiotherapy (IMRT) can be a safe modality for treating spinal bone metastasis with enhanced targeting accuracy and an effective method for achieving good tumor control and a rigorous pain response.<h4>Methods/design</h4>This is a single-center, prospective randomized controlled trial to evaluate pain relief after RT and consists of two treatment groups with 30 patients in each group. One group will receive si ...[more]