Abstract
Bone metastases are a common manifestation of advanced cancer, with pain as a devastating consequence. Due to rising cancer incidence rates and improving survival, the number of cancer patients living long enough to develop bone metastases is increasing rapidly. Metastatic bone pain is difficult to manage and has a detrimental impact on quality of life of patients, their partners and care-givers. Radiation therapy (RT), the standard treatment for palliation of metastatic bone pain, is easy to administer and well tolerated. However, RT is only effective in 60-70% of patients and usually takes four weeks before inducing pain response. Inadequate pain relief is therefore common and alternative treatment options are urgently needed. Pain palliation may be substantially improved by including MR-HIFU as alternative or in addition to RT. Preliminary studies suggest that MR-HIFU induces rapid pain relief (within days), and may palliate pain in patients in whom RT is not effective. Currently, strong evidence and context is lacking for wide-spread implementation of MR-HIFU into routine care. The FURTHER project aims to demonstrate (cost)effectiveness of MR-HIFU as an alternative or additional treatment option to relief metastatic bone pain. For this purpose, a three arm international randomized controlled trial (RCT) including 216 patients will be conducted comparing early and late pain response in patients treated with RT only, MR-HIFU only, and RT with MR-HIFU. A prediction model will be developed to identify patients who are likely to benefit from MR-HIFU in order to allow (cost-) effective use of the treatment. A pilot pathway RCT will be conducted to explore the effectiveness of MR-HIFU as part of a comprehensive pain management strategy. Finally, FURTHER will map and analyse socio-economic barriers for integration of MR-HIFU in routine care in the wider European context and make recommendations on how to provide equal access to this promising new treatment.
Project details
Unibo Team Leader: Alessio Giuseppe Morganti
Coordinator:
Universitair Medisch Centrum Utrecht (Umcu)(Netherlands)
Other Participants:
CENTRO SANA SERVIZI SANITARI PRIVATI srl
(Italy)
Universitaet Zu Koeln
(Germany)
ALMA MATER STUDIORUM - Università di Bologna
(Italy)
The Institute of Cancer Research
(United Kingdom)
"Sapienza" Universita' Di Roma
(Italy)
Istituto Ortopedico Rizzoli
(Italy)
Stichting Isala Klinieken
(Netherlands)
Varsinais-Suomen Sairaanhoitopiirin Kuntayhtyma-Turku University Central Hospital
(Finland)
Focused Ultrasound Foundation
(United States of America)
Total Eu Contribution: Euro (EUR) 3.998.125,00
Project Duration in months: 60
Start Date:
01/01/2019
End Date:
31/12/2023
This project contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 825859