Femoral Bone Metastases

Not Applicable

Recruiting

• Conditions: Cancer; Risk of Fracture; Metastatic Malignant Neoplasm to Femur
• Interventions: Procedure: Surgery Alone; Other: Combined Surgery and Radiation therapy

• Registration Number: NCT01428895
• Lead Sponsor: University Health Network, Toronto

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 Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-09-02
• Study First Posted: 2011-09-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery Alone	Surgery Alone	-
Surgery + Radiation Therapy	Combined Surgery and Radiation therapy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

University Health Network, Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada