Clinical trial · Interventional
Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers
A Randomized Controlled Trial of Early Prophylactic Radiotherapy to Prevent Bone Complications in Patients With Metastatic Solid Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic External Beam Radiotherapy | Radiation | — | UNRESOLVED |
| Standard of Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prophylactic Radiotherapy + Standard of Care
- description
- Participants receive prophylactic external-beam radiotherapy (25 Gy in 5 fractions) to up to five high-risk asymptomatic or minimally symptomatic bone metastases, in addition to standard of care systemic therapy or observation.
- interventionNames
- Radiation: Prophylactic External Beam Radiotherapy
- Other: Standard of Care
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- description
- Participants receive standard of care systemic therapy or observation according to tumor type and clinical guidelines, without prophylactic radiotherapy.
- interventionNames
- Other: Standard of Care
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available