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Preventive radiation may stop bone metastases from causing fractures

NCT ID NCT07146074

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    8 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AZ Delta

    RECRUITING

    Roeselare, 8800, Belgium

  • AZ Groeninge

    RECRUITING

    Kortrijk, 8500, Belgium

  • AZ Turnhout

    RECRUITING

    Turnhout, 2300, Belgium

  • AZORG

    RECRUITING

    Aalst, 9300, Belgium

  • Jessa Ziekenhuis

    NOT_YET_RECRUITING

    Hasselt, 3500, Belgium

  • UZ Gent

    RECRUITING

    Ghent, 9000, Belgium

  • UZ Leuven Gasthuisberg

    NOT_YET_RECRUITING

    Leuven, 3000, Belgium

  • ZAS Augustinus

    RECRUITING

    Wilrijk, Antwerp, 2610, Belgium

    Contact Email: •••••@•••••

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