Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases
Not Applicable
Recruiting
- Conditions
- Bone MetastasesRadiation TherapyPain
- Interventions
- Radiation: SBRT
- 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
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
- Arm && Interventions
Group Intervention Description SBRT with 9 Gy x 3 fractions to the treatment site. SBRT Patients will be treated with SBRT delivering 9 Gy x 3 fractions (BED10: 51.3 Gy) to the treatment site. SBRT with 7 Gy x 5 fractions to the treatment site SBRT Patients will be treated with SBRT delivering 7 Gy x 5 fractions (BED10: 59.5 Gy) to the treatment site.
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Kantonsspital Winterthur
🇨🇭Winterthur, Kanton Zürich, Switzerland
University Hospital Bern
🇨🇭Bern, Switzerland