Cancer, Metastatic Malignant Neoplasm to Femur, Risk of Fracture
Conditions
Keywords
Bone Metastases, Femoral Metastases
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.
Interventions
PROCEDURESurgery Alone
Although we are looking at two groups, this intervention is not protocol specific but is part of the patient's standard management plan. The protocol specific part of the study is completely observational. This involves data being recorded by the attending physician during assessment and patient accounts recorded in the form of questionnaires.
OTHERCombined Surgery and Radiation therapy
Although we are looking at two groups, this intervention is not protocol specific but is part of the patient's standard management plan. The protocol specific part of the study is completely observational. This involves data being recorded by the attending physician during assessment and patient accounts recorded in the form of questionnaires.
Sponsors
University Health Network, Toronto
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To describe the ambulatory status at 3 months by intervention (surgery ± radiotherapy, and radiotherapy alone group) - Ambulatory status | 6 months | Patient will be assessed at baseline, 6 weeks, 3 months and 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Patients will be assessed at baseline, 6 weeks, 3 months and 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 | Patient will be assessed at baseline, 6 weeks, 3 months, and 6 months. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORRebecca Wong, MB ChB
University Health Network, Princess Margaret Hospital
PRINCIPAL_INVESTIGATORPeter Ferguson, MD
Mount Sinai Hospital, Canada
Outcome results
None listed