Femoral Bone Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01428895
First received: May 19, 2011
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Cancer
Metastatic Malignant Neoplasm to Femur
Risk of Fracture
Procedure: Surgery Alone
Other: Combined Surgery and Radiation therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • To describe the ambulatory status at 3 months by intervention (surgery ± radiotherapy, and radiotherapy alone group) - Ambulatory status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patient will be assessed at baseline, 6 weeks, 3 months and 6 months


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patient will be assessed at baseline, 6 weeks, 3 months, and 6 months.


Estimated Enrollment: 180
Study Start Date: March 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428895

Contacts
Contact: Rebecca Wong, MB ChB 416 946 4501 ext 2126 Rebecca.wong@rmp.uhn.on.ca

Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Rebecca Wong, MB ChB    416 946 4501 ext 2126    Rebecca.Wong@rmp.uhn.on.ca   
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Peter Ferguson, MD    416 586-4800 ext 8687    PFerguson@mtsinai.on.ca   
Sponsors and Collaborators
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, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01428895     History of Changes
Other Study ID Numbers: OCREB 09-004
Study First Received: May 19, 2011
Last Updated: June 2, 2014
Health Authority: Canada: Research Ethics Committee

Keywords provided by University Health Network, Toronto:
Bone Metastases
Femoral Metastases

Additional relevant MeSH terms:
Neoplasms
Fractures, Bone
Fractures, Spontaneous
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplasms, Second Primary
Wounds and Injuries
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on July 28, 2014