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
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 adequ...
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| Format: | Article |
| Language: | English |
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BMC
2022-12-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06942-1 |
| _version_ | 1797973508400087040 |
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| author | Derk J. Slotman Marcia M. T. J. Bartels Cyril J. Ferrer Clemens Bos Lambertus W. Bartels Martijn F. Boomsma Erik C. J. Phernambucq Ingrid M. Nijholt Alessio G. Morganti Giambattista Siepe Milly Buwenge Holger Grüll Grischa Bratke Sin Yuin Yeo Roberto Blanco Sequeiros Heikki Minn Mira Huhtala Alessandro Napoli Francesca De Felice Carlo Catalano Alberto Bazzocchi Chiara Gasperini Laura Campanacci Julia Simões Corrêa Galendi Dirk Müller Manon N. G. J. A. Braat Chrit Moonen Helena M. Verkooijen on behalf of the FURTHER consortium |
| author_facet | Derk J. Slotman Marcia M. T. J. Bartels Cyril J. Ferrer Clemens Bos Lambertus W. Bartels Martijn F. Boomsma Erik C. J. Phernambucq Ingrid M. Nijholt Alessio G. Morganti Giambattista Siepe Milly Buwenge Holger Grüll Grischa Bratke Sin Yuin Yeo Roberto Blanco Sequeiros Heikki Minn Mira Huhtala Alessandro Napoli Francesca De Felice Carlo Catalano Alberto Bazzocchi Chiara Gasperini Laura Campanacci Julia Simões Corrêa Galendi Dirk Müller Manon N. G. J. A. Braat Chrit Moonen Helena M. Verkooijen on behalf of the FURTHER consortium |
| author_sort | Derk J. Slotman |
| collection | DOAJ |
| description | 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. 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. |
| first_indexed | 2024-04-11T04:05:04Z |
| format | Article |
| id | doaj.art-4b6e2fb15a014c25b91bf75070a51589 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-11T04:05:04Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-4b6e2fb15a014c25b91bf75070a515892023-01-01T12:26:59ZengBMCTrials1745-62152022-12-0123111010.1186/s13063-022-06942-1Focused Ultrasound and RadioTHERapy for non-invasive palliative pain treatment in patients with bone metastasis: a study protocol for the three armed randomized controlled FURTHER trialDerk J. Slotman0Marcia M. T. J. Bartels1Cyril J. Ferrer2Clemens Bos3Lambertus W. Bartels4Martijn F. Boomsma5Erik C. J. Phernambucq6Ingrid M. Nijholt7Alessio G. Morganti8Giambattista Siepe9Milly Buwenge10Holger Grüll11Grischa Bratke12Sin Yuin Yeo13Roberto Blanco Sequeiros14Heikki Minn15Mira Huhtala16Alessandro Napoli17Francesca De Felice18Carlo Catalano19Alberto Bazzocchi20Chiara Gasperini21Laura Campanacci22Julia Simões Corrêa Galendi23Dirk Müller24Manon N. G. J. A. Braat25Chrit Moonen26Helena M. Verkooijen27on behalf of the FURTHER consortiumDivision of Imaging and Oncology, University Medical Centre UtrechtDivision of Imaging and Oncology, University Medical Centre UtrechtDivision of Imaging and Oncology, University Medical Centre UtrechtDivision of Imaging and Oncology, University Medical Centre UtrechtDivision of Imaging and Oncology, University Medical Centre UtrechtDivision of Imaging and Oncology, University Medical Centre UtrechtDepartment of Radiation Oncology, Isala HospitalDepartment of Radiology, Isala HospitalDIMES, Alma Mater Studiorum - Bologna UniversityRadiation Oncology, IRCCS Azienda Ospedaliero-Universitaria Di BolognaDIMES, Alma Mater Studiorum - Bologna UniversityInstitute of Diagnostic and Interventional Radiology, Faculty of Medicine and University Hospital Cologne, University of CologneInstitute of Diagnostic and Interventional Radiology, Faculty of Medicine and University Hospital Cologne, University of CologneInstitute of Diagnostic and Interventional Radiology, Faculty of Medicine and University Hospital Cologne, University of CologneDepartment of Radiology, Turku University HospitalDepartment of Oncology, University of Turku and Turku University HospitalDepartment of Oncology, University of Turku and Turku University HospitalDepartment of Radiological, Oncological and Pathological Sciences, Sapienza University of RomeDepartment of Radiological, Oncological and Pathological Sciences, Sapienza University of RomeDepartment of Radiological, Oncological and Pathological Sciences, Sapienza University of RomeDiagnostic and Interventional Radiology, IRCCS Istituto Ortopedico RizzoliDiagnostic and Interventional Radiology, IRCCS Istituto Ortopedico Rizzoli3Rd Orthopaedic and Traumatologic Clinic Prevalently Oncologic, IRCCS Istituto Ortopedico RizzoliInstitute of Health Economics and Clinical Epidemiology, Faculty of Medicine and University Hospital of Cologne, University of CologneInstitute of Health Economics and Clinical Epidemiology, Faculty of Medicine and University Hospital of Cologne, University of CologneDivision of Imaging and Oncology, University Medical Centre UtrechtDivision of Imaging and Oncology, University Medical Centre UtrechtDivision of Imaging and Oncology, University Medical Centre UtrechtAbstract 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.https://doi.org/10.1186/s13063-022-06942-1(MeSH): Cancer painPalliative carePalliative therapyPain managementNeoplasm metastasisBone metastases |
| spellingShingle | Derk J. Slotman Marcia M. T. J. Bartels Cyril J. Ferrer Clemens Bos Lambertus W. Bartels Martijn F. Boomsma Erik C. J. Phernambucq Ingrid M. Nijholt Alessio G. Morganti Giambattista Siepe Milly Buwenge Holger Grüll Grischa Bratke Sin Yuin Yeo Roberto Blanco Sequeiros Heikki Minn Mira Huhtala Alessandro Napoli Francesca De Felice Carlo Catalano Alberto Bazzocchi Chiara Gasperini Laura Campanacci Julia Simões Corrêa Galendi Dirk Müller Manon N. G. J. A. Braat Chrit Moonen Helena M. Verkooijen on behalf of the FURTHER consortium 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 (MeSH): Cancer pain Palliative care Palliative therapy Pain management Neoplasm metastasis Bone metastases |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | (MeSH): Cancer pain Palliative care Palliative therapy Pain management Neoplasm metastasis Bone metastases |
| url | https://doi.org/10.1186/s13063-022-06942-1 |
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