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NCT Number: NCT05406063

Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases

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.

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Key information

Conditions

Radiation Therapy Bone Metastases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Winterthur, Winterthur, Canton of Zurich, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SBRT

Radiation

Stereotactic multiple fraction radiotherapy

Primary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nidar Batifi, RN

CONTACT

[email protected]

+4152 266 21 21

Robert Foerster, MD

CONTACT

[email protected]

+4152 266 21 21

Sponsors and collaborators

Lead sponsor

Kantonsspital Winterthur KSW

Other

Collaborators

  • Krebsforschung Schweiz, Bern, Switzerland

Registry information

Official study title

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

Acronym: SMILE

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jun 6, 2022
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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