Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases

Pain Clinical Trial

— SMILE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05406063
• Other study ID #: 2022-00631
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2024
• Source: Kantonsspital Winterthur KSW
• Contact: Robert Foerster, MD
• Phone: +4152 266 21 21
• Email: robert.foerster[@]ksw.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis
• Pain
• Radiation Therapy

Intervention

Radiation:
• SBRT
Stereotactic multiple fraction radiotherapy

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern
Switzerland	Kantonsspital Winterthur	Winterthur	Kanton Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW	Krebsforschung Schweiz, Bern, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 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