Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases

Not Applicable

Recruiting

• Conditions: Bone Metastases; Radiation Therapy; Pain

• Registration Number: NCT05406063
• Lead Sponsor: Kantonsspital Winterthur KSW

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-03
• Study Start: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2025-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 162

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment.	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.

Trial Locations

Locations (2)

Kantonsspital Winterthur; 🇨🇭 Winterthur, Kanton Zürich, Switzerland

University Hospital Bern; 🇨🇭 Bern, Switzerland