Femoral Bone Metastases

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01428895
• Other study ID #: OCREB 09-004
• Status: Recruiting
• Phase: N/A
• Start date: March 2009
• Est. completion date: February 2025

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: Rebecca Wong, MB ChB
• Phone: 416 946 4501
• Email: Rebecca.wong[@]rmp.uhn.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Metastatic Malignant Neoplasm to Femur
• Neoplasm Metastasis
• Neoplasms
• Risk of Fracture

Intervention

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.

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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	University Health Network, Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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