ROBOMET: A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Single fraction of 8 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. |
Radiation: 3D-conformal radiotherapy
In the standard setting, 95% of the PTV should receive 95% of the prescribed dose while near maximum dose (Dnear-max) in the PTV should not exceed 107%. Image-guidance will consist of portal images showing the relevant bony anatomy.
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| Experimental: Single fraction of 20 Gy 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.). |
Radiation: Stereotactic body radiotherapy
Treatment will be prescribed to the periphery of the target, i.e. 80% of the dose should cover 95% of the PTV. The organ at risk (OAR) dose constraints will be in accordance with the recommendations from the report of the American Association of Physicists in Medicine (AAPM) task group 101. Image-guidance will consist of cone-beam CT in combination with 6 degrees of freedom corrections using robotic couch.
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Outcome Measures
Primary Outcome Measures
- Pain response [4 weeks after RT visit]
Pain response at the treated index site at 1 month after radiotherapy (RT), as defined by the consensus statement.
Secondary Outcome Measures
- Incidence of pain flare [24-48 hours after radiotherapy]
Number of participants with increase in pain score of 2 or more above baseline at the treated site with stable OMED, or an increase of 25% or more in OMED compared with baseline with the pain score stable or 1 point above baseline
- Duration of pain response [2 years after radiotherapy]
Time until pain progression (defined as an increase in pain score of 2 or more above baseline at the treated site with stable daily oral morphine equivalent, or an increase of 25% or more in daily oral morphine equivalent (OMED) compared with baseline with the pain score stable or 1 point above baseline)
- Re-irradiation need [2 years after radiotherapy]
Need for re-irradiation of the treated lesion
- Acute toxicity Measured with CTCAE version 5.0 [3 months after radiotherapy]
Measured with CTCAE version 5.0
- Late toxicity Measured with CTCAE version 5.0 [2 years after radiotherapy]
Measured with CTCAE version 5.0
- Impact of treatment on Quality of Life: EORTC quality of life questionnaire (QLQ) BM22 [2 years after radiotherapy]
Using the EORTC quality of life questionnaire for Bone Metastases (QLQ BM22) to measure impact of bone metastases on QoL [min score 0 - max score 100]. A high score represents a high level of symptomatology. The score is calculated by applying a linear transformation on the scores to each answer of the 22 question-long questionnaire (cfr. EORTC mannual).
- Number of Subsequent Serious Skeletal events [2 years after radiotherapy]
Incidence of symptomatic pathologic fractures, radiation or surgery to bone, and spinal cord compression.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed malignancy.
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Pain score ≥ 2 on a scale from 0 to 10.
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Radiological or (bone) scintigraphic evidence of bone metastasis at the site of pain.
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Lesions ≤ 5cm in largest diameter.
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Per lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below.
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No more than 3 painful lesions needing treatment.
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Life expectancy estimated at > 3 months.
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Patients who have received the information sheet and signed the informed consent form.
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Patients must be willing to comply with scheduled visits, treatment plan, and other study procedures.
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Patients with a public and/or private health insurance coverage.
Exclusion Criteria:
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Myeloma.
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Bone metastasis in previously irradiated sites.
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Previous radioisotope treatment for bone metastases.
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Complicated bone metastasis, i.e. impending and/or existing pathological fracture, spinal cord compression or cauda equina compression [16].
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Patients with significantly altered mental status or with psychological, familial, sociological or geographical condition potential hampering compliance with the study.
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Individual deprived of liberty or placed under guardianship.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radiotherapy department, GZA Hospitals | Wilrijk | Antwerp | Belgium | 2610 |
Sponsors and Collaborators
- Cancer Research Antwerp
Investigators
- Study Director: Dirk Verellen, PhD, Iridium Cancer Network
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTOR18072GZA