Clinical trial · Interventional
A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases
A Phase III Randomized-controlled, Single-blind Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases
NCT03831243CI-TRIAL-00073754ROBOMETcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase III randomized-controlled, single-blind study comparing the standard schedule for antalgic radiotherapy of a single fraction of 8.0 Gy delivered through three-dimensional conformal radiotherapy (3D-CRT) to a single fraction of 20.0 Gy delivered through stereotactic body radiotherapy (SBRT). The primary aim of this trial is to double the complete response rate. Secondary aims are to compare general response rates, duration of pain response, acute and late toxicity, HRQoL through patient-reported outcome measures (PROMs), pain flare, and re-irradiation need.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastasis to Bone | — | UNRESOLVED | — |
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D-conformal radiotherapy | Radiation | — | UNRESOLVED |
| Stereotactic body radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Single fraction of 8 Gy
- description
- The current standard treatment will be prescribed, i.e. a 3D-conformal radiotherapy of a single fraction dose of 8.0 Gy to the metastasis with a planning target volume (PTV) margin for set-up and positioning uncertainties of 1 cm. This can be performed at any linear accelerator.
- interventionNames
- Radiation: 3D-conformal radiotherapy
- type
- EXPERIMENTAL
- label
- Single fraction of 20 Gy
- description
- Within the framework of stereotactic body radiotherapy, a single fraction dose of 20.0 Gy will be delivered to the metastasis using a PTV margin of 3-5 mm based on high-precision image-guided radiotherapy (IGRT). Therefore, only linear accelerators with the European Organization for Radiotherapy \& Oncology advisory committee on radiation oncology practice (ESTRO-ACROP) specifications for SBRT can be accepted. A risk-adapted approach will be applied, aiming for the highest possible dose no less than 16 Gy, while respecting the tolerances of critical organs at risk (e.g. spinal cord, cauda equina, brainstem etc.).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed malignancy. * Pain score ≥ 2 on a scale from 0 to 10. * Radiological or (bone) scintigraphic evidence of bone metastasis at the site of pain. * Lesions ≤ 5cm in largest diameter. * Per lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below. * No more than 3 painful lesions needing treatment. * Life expectancy estimated at \> 3 months. * Patients who have received the information sheet and signed the informed consent form. * Patients must be willing to comply with scheduled visits, treatment plan, and other study procedures. * Patients with a public and/or private health insurance coverage. Exclusion Criteria: * Myeloma. * Bone metastasis in previously irradiated sites. * Previous radioisotope treatment for bone metastases. * Complicated bone metastasis, i.e. impending and/or existing pathological fracture, spinal cord compression or cauda equina compression \[16\]. * Patients with significantly altered mental status or with psychological, familial, sociological or geographical condition potential hampering compliance with the study. * Individual deprived of liberty or placed under guardianship.
References
Publications (2)
- DERIVEDMercier C, Billiet C, Ost P, Vandecasteele K, De Kerf G, Claessens M, Van Laere S, Vermeulen P, Dirix L, Lievens Y, Verellen D, Dirix P. Dose-Escalated Stereotactic Versus Conventional Radiotherapy for Painful Bone Metastases (ROBOMET): A Multicenter, Patient-Blinded Randomized Clinical Trial. J Clin Oncol. 2025 Jul;43(19):2164-2172. doi: 10.1200/JCO-24-01447. Epub 2025 May 8. PMID 40340551
- DERIVEDMercier C, Dirix P, Ost P, Billiet C, Joye I, Vermeulen P, Lievens Y, Verellen D. A phase III randomized-controlled, single-blind trial to improve quality of life with stereotactic body radiotherapy for patients with painful bone metastases (ROBOMET). BMC Cancer. 2019 Sep 4;19(1):876. doi: 10.1186/s12885-019-6097-z. PMID 31484505