Preventive radiation may stop bone metastases from causing fractures
NCT ID NCT07146074
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving radiotherapy early to high-risk bone metastases that are not yet causing symptoms can prevent future bone complications like fractures. About 120 adults with solid tumors and at least three bone metastases will be randomly assigned to either standard care (medication or observation) or standard care plus radiotherapy. Researchers will track how long it takes for a bone complication or death to occur, and compare hospitalization rates and quality of life between the two groups.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiotherapy
- What this could lead to
- If it works, this could reduce fractures and other bone complications in cancer patients with bone metastases, improving quality of life.
- What could go wrong
- This is a relatively small Phase 3 trial (120 participants) and the benefit of early radiotherapy over observation alone is not yet proven. Side effects from radiation are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * I1: Histologically confirmed solid tumor malignancy (with polymetastastic spread (≥ 3 metastases)) * I2: High-risk bone metastasis(es) that is (are) asymptomatic or minimally symptomatic: \*Asymptomatic or minimally symptomatic is defined as follows: O Numeric Pain Rating Scale (NRS) score ≤2 for the specific lesion(s) \*High-risk is defined as follows (i.e. at least one of the following points must be applicable): O Bulky site of disease in bone (diameter ≥ 2 cm) O Disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints O Disease in long bones with cortical involvement of \>1/3 in proportion to the diameter of the bone (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpals, phalanges) O Disease in vertebrae of the junctional spine (C1-2, C7- T1, T12-L1, L5-S1) and/or disease with posterior element involvement or epidural extension (Bilsky epidural compression score 1a-3) \[Bilsky et al\]. The posterior elements of the spine consist of the pedicles, laminae, facets (articular processes), transverse processes, and the spinous process. * I3: Number of Risk Factors (NRF) prognostic score 0-2 * I4: Age ≥ 18 years * I5: Ability to provide informed consent (either by the patient or by a legally authorized representative) * I6: A female participant is eligible to participate if she confirms not to be pregnant at screening, and one of the following conditions applies: Is not a woman of child bearing potential or A woman of child bearing potential must confirm that she is not pregnant at screening and must agree to use a very effective method of birth control Exclusion Criteria: * E1: Previous RT to the target treatment site(s) * E2: NRF prognostic score 3 * E3: Serious medical co-morbidities that preclude radiotherapy * E4: Bone lesion complicated with a pathological fracture or impending pathologic fracture for which prophylactic stabilization is recommended, characterized by Mirels score of ≥9 \[Mirels et al\]. * E5: Spinal metastasis with SINS score \>13 requiring upfront neurosurgical stabilization \[Fourney et al\]. * E6: More than 5 high-risk asymptomatic or minimally symptomatic metastatic bone locations * E7: Patient already included in another clinical trial that would interfere with the HERMES clinical trial, as assessed by the Investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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AZ Delta
RECRUITINGRoeselare, 8800, Belgium
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AZ Groeninge
RECRUITINGKortrijk, 8500, Belgium
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AZ Turnhout
RECRUITINGTurnhout, 2300, Belgium
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AZORG
RECRUITINGAalst, 9300, Belgium
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Jessa Ziekenhuis
NOT_YET_RECRUITINGHasselt, 3500, Belgium
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UZ Gent
RECRUITINGGhent, 9000, Belgium
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UZ Leuven Gasthuisberg
NOT_YET_RECRUITINGLeuven, 3000, Belgium
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ZAS Augustinus
RECRUITINGWilrijk, Antwerp, 2610, Belgium
Contact Email: •••••@•••••
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