Post-operative RadioTherapy for patients with metastases of the long bones
- Conditions
- metastatic bone diseaseskeletal metastasis10028389
- Registration Number
- NL-OMON45060
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
- 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)
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint is patient reported pain according to a numeric rating scale<br /><br>(NRS).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Clinical functioning, radiological status, complications (including revisions)<br /><br>and survival are secondary endpoints. </p><br>