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NCT Number: NCT01428895

Femoral Bone Metastases

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Metastatic Malignant Neoplasm to Femur Neoplasms Risk of Fracture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. To describe the ambulatory status at 3 months by intervention (surgery ± radiotherapy, and radiotherapy alone group) - Ambulatory status

    Time frame: 6 months

    Patient will be assessed at baseline, 6 weeks, 3 months and 6 months

Secondary outcomes

  1. 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

    Patients will be assessed at baseline, 6 weeks, 3 months and 6 months

  2. 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

    Patient will be assessed at baseline, 6 weeks, 3 months, and 6 months.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2027
Study completion
2027
First posted
Sep 5, 2011
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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