RecruitingNot ApplicableNCT05406063

Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases

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

Sponsor

Kantonsspital Winterthur KSW

Enrollment

162 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Pain Bone Metastases Radiation Therapy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria9

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.