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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Metastatic Malignant Neoplasm to Femur; Risk of Fracture
• Intervention / Treatment: Procedure: Surgery Alone; Other: Combined Surgery and Radiation therapy

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Wong, MB ChB; Phone Number: 2126 416 946 4501; Email: Rebecca.Wong@rmp.uhn.on.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Peter Ferguson, MD; Phone Number: 8687 416 586-4800; Email: PFerguson@mtsinai.on.ca
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • University Health Network, Princess Margaret Hospital
      • Contact: Rebecca Wong, MB ChB; Phone Number: 2126 416 946 4501; Email: Rebecca.Wong@rmp.uhn.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Surgery Alone	Procedure: Surgery 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.
Active Comparator: Surgery + Radiation Therapy	Other: Combined 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe the ambulatory status at 3 months by intervention (surgery ± radiotherapy, and radiotherapy alone group) - Ambulatory status	Patient will be assessed at baseline, 6 weeks, 3 months and 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Patients will be assessed at baseline, 6 weeks, 3 months and 6 months	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	Patient will be assessed at baseline, 6 weeks, 3 months, and 6 months.	6 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Rebecca Wong, MB ChB, University Health Network, Princess Margaret Hospital; Principal Investigator: Peter Ferguson, MD, Mount Sinai Hospital, Canada

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: May 19, 2011
• First Submitted That Met QC Criteria: September 2, 2011
• First Posted (Estimated): September 5, 2011

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Bone Metastases; Femoral Metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: OCREB 09-004