Early Radiotherapy Versus Observation for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases

Summary

The goal of this clinical trial is to learn whether radiotherapy (i.e. treatment with ionizing radiation to destroy cancer cells) can prevent symptoms in patients with metastatic cancer, having high-risk bone metastases that currently result in no or only mild symptoms. High-risk bone metastases are bone metastases at high-risk of developing bone complications, such as fractures or myelum compression. The main questions this study aims to answer are: * Can preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases (and observation or medication) decrease the number of skeletal related events (i.e. bone complications due to bone metastases) in patients with metastatic cancer? * Can preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases (and observation or medication) decrease the need for hospitalization related to such bone metastases, improve overall survival and (health-related) quality of life? * What are the side effects of preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases? Researchers will compare 2 treatment groups in order to answer the questions listed above: 1 group treated with medication or observation alone (group A) and 1 group treated with medication or observation and preventive radiotherapy (group B). Participants will * be screened to assess whether they are eligible to participate in the study. * be randomized (i.e. drawn) into the 2 treatment groups mentioned above. * be treated with preventive radiotherapy if they were drawn in treatment group B. * need to attend follow-up visits (may be via teleconsultation) at 1, 3, 6, 12, 18 and 24 months after date of randomization during which safety and efficacy is monitored. During these follow-up visits, the general health condition of the participant is evaluated, the occurrence of any bone complication, the medications taken by the participant are registered, the degree of pain and location of the high-risk bone metastases are determined and possible side effects are registered. Furthermore, the participant needs to complete 2 questionnaires at each visit regarding his/her quality of life.

Eligibility

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.

Conditions5

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