Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases

Study Overview
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Brief Summary
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To investigate, whether multi-fraction stereotactic body radiation therapy (SBRT) within 3 treatment fractions is non-inferior to the current standard of care of 5 fraction SBRT regarding pain response at 3 months after radiotherapy.

Official Title
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Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases a Multicentre Prospective, Open Label, Randomised Controlled Phase 3 Non-inferiority Clinical Trial

Conditions
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Radiation Therapy, Bone Metastases, Pain

Intervention / Treatment
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* Radiation: SBRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Personally signed and dated written informed consent, Histological diagnosis of malignancy, Histologically or radiologically diagnosed bone metastasis, Age ≥ 18 years Pain or under pain control medication Exclusion Criteria: Pregnant or lactating women, Women of childbearing potential or sexually active males not willing to use effective contraception while on treatment and 3 months after the end of treatment, Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc., Prior radiotherapy to the intended treatment site, Lesions > 5cm in maximum diameter, Prior treatment with radioactive isotopes within 30 days of randomisation, Spinal column, hands, feet, or head as intended treatment site,- Fracture at the intended treatment site, Surgery required or previous surgery at the intended treatment site Instability of the intended treatment site.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT with 9 Gy x 3 fractions to the treatment site.<br>Patients will be treated with SBRT delivering 9 Gy x 3 fractions (BED10: 51.3 Gy) to the treatment site. | Radiation: SBRT<br>* Stereotactic multiple fraction radiotherapy<br>|
| Active Comparator: SBRT with 7 Gy x 5 fractions to the treatment site<br>Patients will be treated with SBRT delivering 7 Gy x 5 fractions (BED10: 59.5 Gy) to the treatment site. | Radiation: SBRT<br>* Stereotactic multiple fraction radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment. | The Visual Analog Scale is a validated, subjective measure for pain. Possible scores ranges between zero (no pain) and ten (worst possible pain). The primary endpoint was defined as pain relief > 2 points from Baseline to 3 months after treatment. | Baseline and 3 months after treatment |