A Prospective Cohort Study of the Role of Surgery and/or Radiotherapy for Bone Metastases of the Femur at High Risk of Pathological Fracture
Overview
- Phase
- Not Applicable
- Intervention
- Surgery Alone
- Conditions
- Cancer
- Sponsor
- University Health Network, Toronto
- Enrollment
- 180
- Locations
- 2
- Primary Endpoint
- To describe the ambulatory status at 3 months by intervention (surgery ± radiotherapy, and radiotherapy alone group) - Ambulatory status
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Surgery Alone
Intervention: Surgery Alone
Surgery + Radiation Therapy
Intervention: Combined Surgery and Radiation therapy
Outcomes
Primary Outcomes
To describe the ambulatory status at 3 months by intervention (surgery ± radiotherapy, and radiotherapy alone group) - Ambulatory status
Time Frame: 6 months
Patient will be assessed at baseline, 6 weeks, 3 months and 6 months
Secondary Outcomes
- To describe patterns of management in patients with femoral metastases at high risk of pathological fracture - Perioperative Morbidity and Mortality for surgical patients; pain score and performance status; QOL(6 months)
- To describe patient and disease characteristics of major management groups (surgery ± radiotherapy, radiotherapy alone due to preference, radiotherapy alone due to co-morbid conditions) - Assessment of lower limb function(6 months)