Femoral Bone Metastases

NCT01428895 | Active Not Recruiting

• 1 other identifier: OCREB 09-004
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Metastatic Malignant Neoplasm to Femur; Risk of Fracture

Keywords

Bone Metastases; Femoral Metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 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

Study Arms (2)

Surgery Alone

ACTIVE COMPARATOR

Procedure: Surgery Alone

Surgery + Radiation Therapy

ACTIVE COMPARATOR

Other: Combined Surgery and Radiation therapy

Interventions

Surgery Alone PROCEDURE

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.

Surgery Alone

Combined Surgery and Radiation therapy OTHER

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.

Surgery + Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Surgical consultation for the purpose of obtaining a tissue/histological diagnosis only, not for treatment
• Histological diagnosis of lymphoma

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Surgical Procedures, Operative; Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Rebecca Wong, MB ChB

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

• Peter Ferguson, MD

  Mount Sinai Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: September 5, 2011
• Study Start: March 1, 2009
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CA (2)