Status:
COMPLETED
A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases
Lead Sponsor:
Cancer Research Antwerp
Conditions:
Metastasis to Bone
Radiotherapy
Eligibility:
All Genders
18+ years
Phase:
NA
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 rad...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2023
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT03831243
Start Date
April 9 2019
End Date
October 26 2023
Last Update
February 7 2024
Active Locations (1)
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1
Radiotherapy department, GZA Hospitals
Wilrijk, Antwerp, Belgium, 2610