Slotman, Derk J., Bartels, Marcia M. T. J., Ferrer, Cyril J., Bos, Clemens, Bartels, Lambertus W., Boomsma, Martijn F., Phernambucq, Erik C. J., Nijholt, Ingrid M., Morganti, Alessio G., Siepe, Giambattista, Buwenge, Milly, Gruell, Holger, Bratke, Grischa, Yeo, Sin Yuin, Blanco Sequeiros, Roberto, Minn, Heikki, Huhtala, Mira, Napoli, Alessandro, De Felice, Francesca, Catalano, Carlo, Bazzocchi, Alberto, Gasperini, Chiara ORCID: 0000-0002-5306-0985, Campanacci, Laura, Galendi, Julia Simoes Correa, Mueller, Dirk, Braat, Manon N. G. J. A., Moonen, Chrit and Verkooijen, Helena M. (2022). 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. Trials, 23 (1). LONDON: BMC. ISSN 1745-6215

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Abstract

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

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Slotman, Derk J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bartels, Marcia M. T. J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ferrer, Cyril J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bos, ClemensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bartels, Lambertus W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Boomsma, Martijn F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Phernambucq, Erik C. J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nijholt, Ingrid M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Morganti, Alessio G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Siepe, GiambattistaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Buwenge, MillyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gruell, HolgerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bratke, GrischaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Yeo, Sin YuinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Blanco Sequeiros, RobertoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Minn, HeikkiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Huhtala, MiraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Napoli, AlessandroUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
De Felice, FrancescaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Catalano, CarloUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bazzocchi, AlbertoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gasperini, ChiaraUNSPECIFIEDorcid.org/0000-0002-5306-0985UNSPECIFIED
Campanacci, LauraUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Galendi, Julia Simoes CorreaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Braat, Manon N. G. J. A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Moonen, ChritUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Verkooijen, Helena M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-689522
DOI: 10.1186/s13063-022-06942-1
Journal or Publication Title: Trials
Volume: 23
Number: 1
Date: 2022
Publisher: BMC
Place of Publication: LONDON
ISSN: 1745-6215
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
QUALITY-OF-LIFE; INTERNATIONAL CONSENSUS; EORTC QLQ-C15-PAL; RADIATION-THERAPY; CANCER PAIN; QUESTIONNAIRE; MANAGEMENT; SURGERYMultiple languages
Medicine, Research & ExperimentalMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/68952

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