Clinical Trial: Femoral Bone Metastases

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: University Health Network, Toronto

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: 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 [ Time Frame: 6 months ]
    Patient will be assessed at baseline, 6 weeks, 3 months, and 6 months.


Original Secondary Outcome: Same as current

Information By: University Health Network, Toronto

Dates:
Date Received: May 19, 2011
Date Started: March 2009
Date Completion: December 2017
Last Updated: December 28, 2016
Last Verified: December 2016