Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases
NCT ID: NCT05406063
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
162 participants
INTERVENTIONAL
2022-06-01
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Trial to Improve Quality of Life With Stereotactic Body Radiotherapy for Patients With Painful Bone Metastases
NCT03831243
Stereotactic Body Radiotherapy Followed by Surgical Stabilization in Spinal Metastases
NCT05060653
Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small Cell Lung Cancer, or Prostate Cancer
NCT02206334
Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy for Painful Non-Spine Bone Metastases
NCT06391242
A Study of Stereotactic Body Radiotherapy (SBRT) and Surgical Stabilization for People With Cancer That Has Spread to the Bone
NCT05038124
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SBRT with 9 Gy x 3 fractions to the treatment site.
Patients will be treated with SBRT delivering 9 Gy x 3 fractions (BED10: 51.3 Gy) to the treatment site.
SBRT
Stereotactic multiple fraction radiotherapy
SBRT with 7 Gy x 5 fractions to the treatment site
Patients will be treated with SBRT delivering 7 Gy x 5 fractions (BED10: 59.5 Gy) to the treatment site.
SBRT
Stereotactic multiple fraction radiotherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SBRT
Stereotactic multiple fraction radiotherapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histological diagnosis of malignancy,
* Histologically or radiologically diagnosed bone metastasis,
* Age ≥ 18 years
* Pain or under pain control medication
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Krebsforschung Schweiz, Bern, Switzerland
OTHER
Kantonsspital Winterthur KSW
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Foerster, MD
Role: PRINCIPAL_INVESTIGATOR
Kantonsspital Winterthur KSW
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kantonsspital Winterthur
Winterthur, Canton of Zurich, Switzerland
University Hospital Bern
Bern, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hossein Hemmatazad, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Foerster R, Zwahlen DR, Schroeder C, Windisch P, Halatsch ME, Alfieri A, Meier C, Hemmatazad H, Aebersold DM, Buchali A, Habermehl D, Batifi N. SMILE-stereotactic multiple fraction radiotherapy for non-spine bone metastases: study protocol for a multicenter, open-label phase III randomized controlled trial. Trials. 2024 Nov 13;25(1):762. doi: 10.1186/s13063-024-08608-6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-00631
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.