Prophylactic Radiotherapy to Prevent Bone Complications in Metastatic Cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II, randomized, single-center trial comparing prophylactic external-beam radiotherapy to standard care (systemic therapy or observation) for up to five high-risk bone metastases in adults with metastatic solid tumors. Participants are assigned 1:1 to receive 25 Gy in 5 fractions of prophylactic radiotherapy plus standard care or standard care alone and are followed for 12 months. Outcomes include skeletal-related events, adverse events, quality of life, pain measures, and survival. The study uses CTCAE for toxicity, and validated patient-reported questionnaires to assess quality of life and pain.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Institute of Oncology Ljubljana
  Ljubljana, Slovenia Recruiting

Study contacts

• Study coordinator: Eva Ćirić, MD
• Email: eciric@onko-i.si
• Phone: +38615879623

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.