TY - JOUR
T1 - Focused Ultrasound and RadioTHERapy for non-invasive palliative pain treatment in patients with bone metastasis
T2 - a study protocol for the three armed randomized controlled FURTHER trial
AU - Slotman, Derk J
AU - Bartels, Marcia M T J
AU - Ferrer, Cyril J
AU - Bos, Clemens
AU - Bartels, Lambertus W
AU - Boomsma, Martijn F
AU - Phernambucq, Erik C J
AU - Nijholt, Ingrid M
AU - Morganti, Alessio G
AU - Siepe, Giambattista
AU - Buwenge, Milly
AU - Grüll, Holger
AU - Bratke, Grischa
AU - Yeo, Sin Yuin
AU - Blanco Sequeiros, Roberto
AU - Minn, Heikki
AU - Huhtala, Mira
AU - Napoli, Alessandro
AU - De Felice, Francesca
AU - Catalano, Carlo
AU - Bazzocchi, Alberto
AU - Gasperini, Chiara
AU - Campanacci, Laura
AU - Simões Corrêa Galendi, Julia
AU - Müller, Dirk
AU - Braat, Manon N G J A
AU - Moonen, Chrit
AU - Verkooijen, Helena M
N1 - Funding Information:
Financial support for this study was provided by the European Union’s Horizon 2020 research and innovation program under grant agreement No 825859. The funder had no role in the study design.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/12/29
Y1 - 2022/12/29
N2 - 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.TRIAL REGISTRATION: The FURTHER trial is registered under the Netherlands Trials Register number NL71303.041.19 and ClinicalTrials.gov registration number NCT04307914. Date of trial registration is 13-01-2020.
AB - 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.TRIAL REGISTRATION: The FURTHER trial is registered under the Netherlands Trials Register number NL71303.041.19 and ClinicalTrials.gov registration number NCT04307914. Date of trial registration is 13-01-2020.
KW - (MeSH): Cancer pain
KW - Bone metastases
KW - High-intensity focused ultrasound ablation
KW - Magnetic resonance imaging interventional
KW - Neoplasm metastasis
KW - Pain management
KW - Palliative care
KW - Palliative therapy
KW - Radiation oncology
KW - Radiotherapy
UR - http://www.scopus.com/inward/record.url?scp=85145138301&partnerID=8YFLogxK
U2 - 10.1186/s13063-022-06942-1
DO - 10.1186/s13063-022-06942-1
M3 - Article
C2 - 36582001
SN - 1745-6215
VL - 23
SP - 1
EP - 10
JO - Trials
JF - Trials
IS - 1
M1 - 1061
ER -