Focused Ultrasound and RadioTHERapy for non-invasive palliative pain treatment in patients with bone metastasis: a study protocol for the three armed randomized controlled FURTHER trial

• DOI: 10.1186/s13063-022-06942-1
• Publication Date: 2022-12-29T08:03:08Z
• Authors: Derk J. Slotman; Marcia M. T. J. B...; Cyril J. Ferrer; Clemens Bos; Lambertus W. Bartels; Martijn F. Boomsma; Erik C. J. Pherna...; Ingrid M. Nijholt; Alessio G. Morganti; Giambattista Siepe; Milly Buwenge; Holger Grüll; Grischa Bratke; Sin Yuin Yeo; Roberto Blanco Se...; Heikki Minn; Mira Huhtala; Alessandro Napoli; Francesca De Felice; Carlo Catalano; Alberto Bazzocchi; Chiara Gasperini; Laura Campanacci; Julia Simões Corr...; Dirk Müller; Manon N. G. J. A....; Chrit Moonen; Helena M. Verkooijen
• Keywords: High-intensity focused ultrasound; External beam radiotherapy; Bone pain

Abstract Background Cancer-induced bone pain (CIBP), caused by metastases, is a common complication of cancer and strongly impairs quality life (QoL). External beam radiotherapy (EBRT) the current standard care for treatment CIBP. However, approximately 45% patients have no adequate response after EBRT. Magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) may improve palliation in this patient population. The main objective trial was to compare MR-HIFU, EBRT, MR-HIFU + EBRT palliative metastases. Methods/design FURTHER an international multicenter, three-armed randomized controlled trial. A total 216 with painful metastases will be 1:1:1 ratio receive only, or combined followed MR-HIFU. During follow-up period 6 months, contacted at eight time points retrieve information about their level pain, QoL, occurrence (serious) adverse events. primary outcome 14 days start treatment. Secondary outcomes include enrolment, scores (daily until 21st day 4, 6, 12 24 weeks), toxicity, events, survival. Cost-effectiveness cost-utility analysis conducted. Discussion aims evaluate effectiveness cost-effectiveness MR-HIFU—alone combination EBRT—compared relieve performed six hospitals four European countries, all which are partners consortium. Trial registration registered under Netherlands Trials Register number NL71303.041.19 ClinicalTrials.gov NCT04307914. Date 13–01-2020.