Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Prophylactic External Beam Radiotherapy
- Standard of Care
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov