eprintid: 19405 rev_number: 15 eprint_status: archive userid: 1589 dir: disk0/00/01/94/05 datestamp: 2015-12-15 10:34:57 lastmod: 2024-03-15 16:28:02 status_changed: 2015-12-15 10:34:57 type: article metadata_visibility: show creators_name: Rief, Harald creators_name: Katayama, Sonja creators_name: Bruckner, Thomas creators_name: Rieken, Stefan creators_name: Bostel, Tilman creators_name: Förster, Robert creators_name: Schlampp, Ingmar creators_name: Wolf, Robert creators_name: Debus, Jürgen creators_name: Sterzing, Florian title: High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial subjects: ddc-610 divisions: i-911400 divisions: i-911800 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). date: 2015 publisher: BioMed Central id_scheme: DOI ppn_swb: 1655191160 own_urn: urn:nbn:de:bsz:16-heidok-194053 language: eng bibsort: RIEFHARALDHIGHDOSESI2015 full_text_status: public publication: Trials volume: 16 number: 264 place_of_pub: London pagerange: 1-5 issn: 1468-6694 citation: Rief, Harald ; Katayama, Sonja ; Bruckner, Thomas ; Rieken, Stefan ; Bostel, Tilman ; Förster, Robert ; Schlampp, Ingmar ; Wolf, Robert ; Debus, Jürgen ; Sterzing, Florian (2015) High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial. Trials, 16 (264). pp. 1-5. ISSN 1468-6694 document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/19405/1/13063_2015_Article_761.pdf