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Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers
Sponsor: Institute of Oncology Ljubljana
Summary
This is a prospective, randomized, single-center clinical trial evaluating whether early prophylactic radiotherapy to high-risk asymptomatic or minimally symptomatic bone metastases reduces the 1-year rate of skeletal-related events (SREs) in patients with metastatic solid cancers. Patients will be randomized in a 1:1 ratio to receive either standard of care systemic therapy or observation, or prophylactic radiotherapy in addition to standard of care. The primary endpoint is the 1-year rate of SREs. Secondary endpoints include adverse events, quality of life, economic burden, pain-free survival, and overall survival.
Official title: A Randomized Controlled Trial of Early Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2026-06-02
Completion Date
2029-02
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Prophylactic External Beam Radiotherapy
External beam radiotherapy delivered to up to five high-risk asymptomatic or minimally symptomatic bone metastases at a total dose of 25 Gy in 5 fractions.
Standard of Care
Systemic therapy or observation according to tumor type and clinical guidelines.
Locations (1)
Institute of Oncology Ljubljana
Ljubljana, Slovenia