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

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.

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.