Early radiotherapy versus observation for high‑risk painless or minimally painful bone metastases

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 randomized interventional trial compares early targeted radiotherapy to observation with standard systemic care for patients with solid tumors who have polymetastatic disease and one or more high‑risk, asymptomatic or minimally symptomatic bone lesions. High‑risk lesions are defined by size and location (for example hip, shoulder, long bones, or junctional vertebrae), cortical involvement, or epidural extension, and target lesions must have pain ≤2 on the Numeric Rating Scale. The trial measures symptomatic skeletal events (pathologic fracture, spinal cord compression, need for palliative radiotherapy or orthopedic surgery), related hospitalizations, overall survival, health‑related quality of life, and treatment side effects. Participants receive either preventive radiotherapy to high‑risk sites plus usual care or observation/standard systemic therapy, with scheduled follow‑up to capture events and patient‑reported outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• ZAS Augustinus
  Wilrijk, Antwerp, Belgium Recruiting
• Azorg
  Aalst, Belgium Recruiting
• UZ Gent
  Ghent, Belgium Recruiting
• AZ Groeninge
  Kortrijk, Belgium Recruiting
• AZ Delta
  Roeselare, Belgium Recruiting
• AZ Turnhout
  Turnhout, Belgium Recruiting

Study contacts

• Principal investigator: Charlotte Billiet, MD, PhD — Ziekenhuis aan de Stroom
• Study coordinator: Charlotte Billiet, MD, PhD
• Email: cancertrials@zas.be
• Phone: 034433759

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.