Status:
RECRUITING
Early Radiotherapy Versus Observation for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases
Lead Sponsor:
Cancer Research Antwerp
Collaborating Sponsors:
Kom Op Tegen Kanker
Conditions:
Solid Neoplasms
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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-r...
Detailed Description
It is estimated that two out of three patients with advanced cancer will develop metastases in the bones (i.e. bone metastases). Any type of cancer can spread to the bone, but the types of cancer in w...
Eligibility Criteria
Inclusion
- I1: Histologically confirmed solid tumor malignancy (with polymetastastic spread (more than 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
- 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
Key Trial Info
Start Date :
February 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07146074
Start Date
February 5 2025
End Date
February 1 2029
Last Update
August 28 2025
Active Locations (8)
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1
ZAS Augustinus
Wilrijk, Antwerp, Belgium, 2610
2
AZORG
Aalst, Belgium, 9300
3
UZ Gent
Ghent, Belgium, 9000
4
Jessa Ziekenhuis
Hasselt, Belgium, 3500