Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases (SMILE)

May 19, 2025 updated by: Kantonsspital Winterthur KSW

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • University Hospital Bern
        • Contact:
          • Hossein Hemmatazad, MD
    • Kanton Zürich
      • Winterthur, Kanton Zürich, Switzerland, 8401
        • Recruiting
        • Kantonsspital Winterthur
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Foerster, MD
        • Sub-Investigator:
          • Christina Schroeder, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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.
Patients will be treated with SBRT delivering 9 Gy x 3 fractions (BED10: 51.3 Gy) to the treatment site.
Radiation: SBRT
Stereotactic multiple fraction radiotherapy
Active Comparator: SBRT with 7 Gy x 5 fractions to the treatment site
Patients will be treated with SBRT delivering 7 Gy x 5 fractions (BED10: 59.5 Gy) to the treatment site.
Radiation: SBRT
Stereotactic multiple fraction radiotherapy

What is the study measuring?

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.
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.
Baseline and 3 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Winterthur KSW

Collaborators

Krebsforschung Schweiz, Bern, Switzerland

Investigators

  • Principal Investigator: Robert Foerster, MD, Kantonsspital Winterthur KSW

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

June 1, 2022

First Posted (Actual)

June 6, 2022

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-00631

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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