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Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05406063
Acronym
SMILE
Enrollment
162
Registered
2022-06-06
Start date
2022-06-01
Completion date
2026-05-31
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases, Pain, Radiation Therapy

Brief summary

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

RADIATIONSBRT

Stereotactic multiple fraction radiotherapy

Sponsors

Krebsforschung Schweiz, Bern, Switzerland
CollaboratorOTHER
Kantonsspital Winterthur KSW
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment.Baseline and 3 months after treatmentThe 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.

Countries

Switzerland

Contacts

Primary ContactRobert Foerster, MD
robert.foerster@ksw.ch+4152 266 21 21
Backup ContactNidar Batifi, RN
nidar.batifi@ksw.ch+4152 266 21 21

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026