ESTRO 2024 - Abstract Book

S1963

Clinical - Mixed sites, palliation

ESTRO 2024

The FURTHER Consortium leads a randomized-controlled trial (RCT) aimed to assess the effectiveness and financial implications of MRI-HIFU treatment (either alone or in conjunction with EBRT) in comparison to ERBT alone, as a therapeutic option for the relief of bone-metastasis induced pain.

Material/Methods:

The FURTHER trial is a, multicentric RCT subsidized by the European Commission Horizon 2020 program (NCT04307914). The study is conducted in six hospitals in four European countries (Germany, Italy, Finland and the Netherlands) and coordinated by the University Medical Center Utrecht.

Eligible patients are randomized into one of the three intervention arms; patients who do not meet inclusion criteria or do not want to be randomized are included in the FURTHER Registry arm (Figure 1).

Results:

Due to the Covid-19 pandemic, trial enrolment was severly delayed. As such, we have extended the project with 24 months. Currently, 40 patients have been enrolled in the RCT and 9 in the registry. We envision a total enrolment of 129 patients in the RCT and the primary endpoint is pain response at 14 days following treatment. Secondary endpoints include pain response 14 days after randomization, pain response and quality of life over the course of 6 months following treatment and cost-effectiveness. Final results are expected in 2026.

Conclusion:

MR-HIFU treatment has the potential to quickly and effectively alleviate pain at the level of bone site. The FURTHER trial will answer the question whether MR-HIFU +/- EBRT is superior to EBRT alone as a non-invasive treatment for pain palliation of patients with bone metastases.

Keywords: Bone metastasis, MRI-HIFU, radiotherapy

References:

Slotman DJ, Bartels MMTJ, Ferrer CJ, Bos C, Bartels LW, Boomsma MF, Phernambucq ECJ, Nijholt IM, Morganti AG, Siepe G, Buwenge M, Grüll H, Bratke G, Yeo SY, Blanco Sequeiros R, Minn H, Huhtala M, Napoli A, De Felice F, Catalano C, Bazzocchi A, Gasperini C, Campanacci L, Simões Corrêa Galendi J, Müller D, Braat MNGJA, Moonen C, Verkooijen HM; 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. 2022;23(1):1061. doi: 10.1186/s13063-022-06942-1. Simões Corrêa Galendi J, Siefen AC, Moretti DM, Yeo SY, Grüll H, Bratke G, Morganti AG, Bazzocchi A, Gasperini C, De Felice F, Blanco Sequeiros R, Huhtala M, Nijholt IM, Boomsma MF, Bos C, Verkooijen HM, Müller D, Stock S. Factors Influencing the Adoption of Magnetic Resonance-Guided High-Intensity Focused Ultrasound for Painful Bone Metastases in Europe, A Group Concept Mapping Study. Int J Environ Res Public Health. 2023;20(2):1084. doi: 10.3390/ijerph20021084.