Clinical trial NCT01428895: Femoral Bone Metastases
Official title: A Prospective Cohort Study of the Role of Surgery and/or Radiotherapy for Bone Metastases of the Femur at High Risk of Pathological Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Metastatic Malignant Neoplasm to Femur
Risk of Fracture
Keywords: Bone Metastases
Femoral Metastases
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2011-09-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: To describe the ambulatory status at 3 months by intervention (surgery ± radiotherapy, and radiotherapy alone group) - Ambulatory status
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Princess Margaret Hospital
name: Rebecca Wong, MB ChB
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Hospital, Canada
name: Peter Ferguson, MD
role: PRINCIPAL_INVESTIGATOR
References: