metastatic bone disease skeletal metastasis
Conditions
Interventions
One study group (A) will receive surgery only
the other study group (B) will
receive surgery with adjuvant radiotherapy.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Aged 18 or older - Receive surgical treatment (prosthesis, intramedullary nail, plate, curettage with/without cement) with palliative intent for a pathologic fracture or impending pathologic fracture of the extremities (humerus/femur and further distal) due to metastatic bone disease - Radiographic or histologic proof of metastatic bone disease - Histologic diagnosis of the primary tumour or * if the diagnosis is unknown - at least adequate diagnostic investigations into the origin of the metastasis (e.g. dissemination imaging, histology, biopsy)
Exclusion criteria
Exclusion criteria: - Communication with patient is hampered (e.g. language barrier, severe cognitive impairment, dementia) - The treated lesion originates from multiple myeloma, solitary plasmacytoma or lymphoma of bone - Further radiotherapy is considered inappropriate (> 2 series RT on current lesion) - Physically unable to undergo post-operative RT treatment, according to treating doctor*s opinion - Absolute need for post-operative treatment with radiotherapy, specify reason: o Pain o Extent of bone lesion (outside surgical field) o Soft tissue involvement o Curative intent of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is patient reported pain according to a numeric rating scale (NRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical functioning, radiological status, complications (including revisions) and survival are secondary endpoints. | — |
Countries
Netherlands
Outcome results
None listed