A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases (ROBOMET)
Metastasis to Bone, Radiotherapy, Neoplasm Metastasis
About this trial
This is an interventional treatment trial for Metastasis to Bone focused on measuring Stereotactic Body Radiotherapy, Spinal metastases, Bone metastases
Eligibility Criteria
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.
Sites / Locations
- Radiotherapy department, GZA HospitalsRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Single fraction of 8 Gy
Single fraction of 20 Gy
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.
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.).