Journal of Clinical Oncology

Dose-Escalated Stereotactic Versus Conventional Radiotherapy for Painful Bone Metastases (ROBOMET): A Multicenter, Patient-Blinded Randomized Clinical Trial

C Carole Mercier (Iridium Kankernetwerk, Antwerpen, Belgium) C Charlotte Billiet (Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...) P Piet Ost K Katrien Vandecasteele (Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...) G Geert De Kerf (Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...) M Michaël Claessens (Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...) S Steven Van Laere P Peter Vermeulen L Luc Dirix (Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...) Y Yolande Lievens (Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...) D Dirk Verellen (Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...) P Piet Dirix (Iridium Network, Wilrijk, Belgium)

Abstract

PURPOSE To test whether dose-escalated single fraction (SF) stereotactic body radiotherapy (SBRT) of 20 Gy to painful bone metastases is superior to conventional SF three-dimensional (3D) conformal radiotherapy (RT) to a standard dose of 8 Gy in achieving complete pain response (CR). METHODS A single-blind, randomized, controlled, phase III trial (ROBOMET) included 126 patients with up to three painful bone metastases, randomly assigned between April 2019 and October 2022 at multiple centers in Belgium. Inclusion criteria were uncomplicated painful bone metastases (worst pain score ≥2 on a 0-10 pain scale) arising from a solid tumor. Treatment consisted of either a single SBRT fraction of 20 Gy or a single conventional RT fraction of 8 Gy. The primary end point was the proportion of patients with a CR 1 month after RT scored according to the International Consensus on Palliative Radiotherapy Endpoints analyzed as per an intention-to-treat principle. RESULTS After 1 month, 16 of 63 (25% [95% CI, 15 to 38]) patients treated with conventional RT achieved CR versus 23 of 63 (37% [95% CI, 25 to 50]) treated with SBRT ( P = .25). After 3 months, 15 of 63 (24% [95% CI, 14 to 36]) patients achieved CR after conventional RT versus 21 of 63 (33% [95% CI, 22 to 46]) after SBRT ( P = .32). Among patients evaluable after 3 months and treated per protocol, the SBRT group had more complete responders (21/39, 54% [95% CI, 37 to 70]) than the conventional RT group (15/48, 31% [95% CI, 19 to 46]; P = .048). CONCLUSION SBRT failed to demonstrate improved CR rates after 1 month.

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Article Details

Volume / Issue Vol. 43, Issue 19
Published July 01, 2025
Pages 2164-2172
ISSN 0732-183X
Publisher Lippincott Williams & Wilkins

Journal Info

Journal of Clinical Oncology

Lippincott Williams & Wilkins
ISSN: 0732-183X Health Sciences

Authors (12)

C

Carole Mercier

Iridium Kankernetwerk, Antwerpen, Belgium

C

Charlotte Billiet

Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...

P

Piet Ost

K

Katrien Vandecasteele

Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...

G

Geert De Kerf

Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...

M

Michaël Claessens

Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...

S

Steven Van Laere

P

Peter Vermeulen

L

Luc Dirix

Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...

Y

Yolande Lievens

Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...

D

Dirk Verellen

Carole Mercier, MD, and Charlotte Billiet, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Piet Ost, MD, PhD, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Department of Human Structure and Repair, Ghent University, Ghent, Belgium; Katrien Vandecasteele, MD, PhD, Department of Human Structure and Repair, Ghent University, Ghent, Belgium, Department of Radiation Oncology, University Hospital Ghent, Gent, Belgium; Geert De Kerf, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium; Michaël Claessens, PhD, MSc, Department of Radiation Oncology, Iridium Network, Wilrijk, Antwerp, Belgium, Integrated Personalised and Precision Oncology Network, University Antwerp, Antwerp, Belgium; Peter Vermeulen, MD, PhD, Translational Cancer Research Unit (TCRU)—GZA Ziekenhuizen, Wilrijk, Antwerp, Belgium; Luc Dirix, MD, PhD, Departme...

P

Piet Dirix

Iridium Network, Wilrijk, Belgium

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