Clinical trial · Interventional
Femoral Bone Metastases
A Prospective Cohort Study of the Role of Surgery and/or Radiotherapy for Bone Metastases of the Femur at High Risk of Pathological Fracture
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Bone is a common site of metastasis for a range of malignancies. Bone metastases have the potential to cause significant morbidity including pain, impairment of ambulation and reduced functional independence. Previous research has shown that pathological fractures are observed in 9 to 29 percent of patients with long bone metastases, and a high proportion of these require surgical intervention to relieve pain and restore function. The goal of this study is to describe the clinical outcomes of patients with femoral metastases at high risk of pathological fracture. Patients referred for treatment of femoral metastases at high risk of fracture will be followed prospectively after undergoing with surgery (± post-operative radiotherapy), or radiotherapy alone. Patient and disease characteristics, ambulatory status and limb function will be documented before treatment. These Clinical outcomes of participants in each treatment group will be measured 6 weeks after treatment, and 3- and 6 months after enrolment, with particular reference to patient-reported outcomes relating to pain, ambulatory status, limb function and quality of life.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Metastatic Malignant Neoplasm to Femur | — | UNRESOLVED | — |
| Risk of Fracture | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined Surgery and Radiation therapy | Other | — | UNRESOLVED |
| Surgery Alone | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgery Alone
- interventionNames
- Procedure: Surgery Alone
- type
- ACTIVE_COMPARATOR
- label
- Surgery + Radiation Therapy
- interventionNames
- Other: Combined Surgery and Radiation therapy
Primary outcomes (1)
- measure
- To describe the ambulatory status at 3 months by intervention (surgery ± radiotherapy, and radiotherapy alone group) - Ambulatory status
- timeFrame
- 6 months
- description
- Patient will be assessed at baseline, 6 weeks, 3 months and 6 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of malignancy other than lymphoma * Presence of femoral metastases at high risk of pathologic fracture (Mirels' score 8 or more) * At least 18 years of age * Able to provide written informed consent * Able to participate in follow-up Exclusion Criteria: * Surgical consultation for the purpose of obtaining a tissue/histological diagnosis only, not for treatment * Histological diagnosis of lymphoma
References
Publications (0)
Data not yet available