Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SBRT.
- Who it may be relevant to
- Registry conditions: Radiation Therapy, Bone Metastases, Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases a Multicentre Prospective, Open Label, Randomised Controlled Phase 3 Non-inferiority Clinical Trial
Overview
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.
Interventions
- Radiation SBRT
Stereotactic multiple fraction radiotherapy
Primary outcome measures
- Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment. [Time frame: Baseline and 3 months after treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 2 centers
- Kantonsspital Winterthur — Winterthur
- University Hospital Bern — Bern
Publications
- Foerster R, Zwahlen DR, Schroeder C, Windisch P, Halatsch ME, Alfieri A, Meier C, Hemmatazad H, Aebersold DM, Buchali A, Habermehl D, Batifi N. SMILE-stereotactic multiple fraction radiotherapy for non-spine bone metastases: study protocol for a multicenter, open-label phase III randomized controlled trial. Trials. 2024 Nov 13;25(1):762. doi: 10.1186/s13063-024-08608-6. PMID 39538259
Identifiers
NCT: NCT05406063 · 2022-00631