Radiation therapy for bone metastases using fewer treatment sessions
Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases a Multicentre Prospective, Open Label, Randomised Controlled Phase 3 Non-inferiority Clinical Trial
This study is testing if giving radiation therapy for bone metastases in three sessions instead of five can still help reduce pain for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 162 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kantonsspital Winterthur KSW Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Winterthur, Canton of Zurich and 1 other locations) |
| Trial ID | NCT05406063 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of multi-fraction stereotactic body radiation therapy (SBRT) delivered in three treatment sessions compared to the standard five-session approach for patients with bone metastases. The primary focus is on assessing pain response three months after treatment. Participants will receive SBRT, and their pain levels will be monitored to determine if the shorter treatment regimen is equally effective. The study aims to provide a more efficient treatment option for patients suffering from pain due to bone metastases.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a histological diagnosis of malignancy and bone metastases who are experiencing pain.
Not a fit: Patients with prior radiotherapy to the treatment site or those with lesions larger than 5cm may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the number of treatment sessions needed for patients, potentially improving their quality of life and convenience.
How similar studies have performed: Previous studies have shown promising results with stereotactic body radiation therapy for bone metastases, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Winterthur, Canton of Zurich and 1 other locations
- Kantonsspital Winterthur — Winterthur, Canton of Zurich, Switzerland (Recruiting)
- University Hospital Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Robert Foerster, MD — Kantonsspital Winterthur KSW
- Study coordinator: Robert Foerster, MD
- Email: robert.foerster@ksw.ch
- Phone: +4152 266 21 21
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.