Femoral Bone Metastases

Sponsor

University Health Network, Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT01428895

Collaborator

(none)

180

Enrollment

Locations

Arms

167.1

Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Metastatic Malignant Neoplasm to Femur Risk of Fracture	Procedure: Surgery Alone Other: Combined Surgery and Radiation therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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 Start Date :

Mar 1, 2009

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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 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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai Hospital	Toronto	Ontario	Canada	M5G 1X5
2	University Health Network, Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9

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, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT01428895

Other Study ID Numbers:

OCREB 09-004

First Posted:

Sep 5, 2011

Last Update Posted:

Apr 15, 2022

Last Verified:

Apr 1, 2022

Keywords provided by University Health Network, Toronto

Bone Metastases

Femoral Metastases

Additional relevant MeSH terms:

Neoplasm Metastasis

Neoplasms

Study Results

No Results Posted as of Apr 15, 2022