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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment. — Baseline and 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.
Trial sites (2)
Facility
City
Region
Status
Kantonsspital Winterthur
Winterthur
Canton of Zurich
Recruiting
University Hospital Bern
Bern
Switzerland
Recruiting
More Kantonsspital Winterthur KSW trials in Switzerland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.