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

Kantonsspital Winterthur KSW2 sites in 1 country162 target enrollmentJune 1, 2022

ConditionsRadiation Therapy Bone Metastases Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Radiation Therapy
Sponsor: Kantonsspital Winterthur KSW
Enrollment: 162
Locations: 2
Primary Endpoint: Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment.
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 1, 2022

End Date

May 31, 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kantonsspital Winterthur KSW

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.