Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers
Starting soon · Phase 2
Conditions studied: Bone Metastases, Metastatic Solid Tumor
In brief
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.
Key facts
- Study ID
- NCT07540650
- Run by
- Institute of Oncology Ljubljana
- People needed
- 90
- Starts
- 2026-04-01
- Expected to finish
- 2029-02-01
- Last updated by the study team
- 2026-04-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years
- Histologically confirmed solid malignancy
- Metastatic disease confirmed by imaging (CT, MRI, or PET-CT)
- Presence of up to five high-risk bone metastases
- High-risk bone metastases defined according to protocol criteria
- Asymptomatic or minimally symptomatic bone metastases (not requiring opioid analgesics)
- ECOG performance status 0-2
- Ability to provide written informed consent
You may not qualify if…
- Prior radiotherapy to the index bone metastases preventing safe treatment planning
- Symptomatic bone metastases requiring immediate palliative radiotherapy
- Evidence of spinal cord compression
- Bone metastases causing significant pain requiring opioid analgesics
- Oligometastatic disease suitable for radical treatment
- Leptomeningeal disease
- ECOG performance status ≥3
- Life expectancy less than 3 months
- Any condition that, in the investigator's opinion, would interfere with study participation or assessment
Where it is running
- Institute of Oncology Ljubljana — Ljubljana, Slovenia
Full record on ClinicalTrials.gov
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