A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases (ROBOMET)

Cancer Research Antwerp

Status: Completed

Conditions: Radiotherapy; Neoplasm Metastasis; Metastasis to Bone

Treatments: Radiation: Stereotactic body radiotherapy; Radiation: 3D-conformal radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03831243

CTOR18072GZA

Details and patient eligibility

About

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.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Single fraction of 8 Gy

Active Comparator group

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.

Treatment:

Radiation: 3D-conformal radiotherapy

Single fraction of 20 Gy

Experimental group

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.).

Treatment:

Radiation: Stereotactic body radiotherapy