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Femoral Bone Metastases

University Health Network, Toronto logo

University Health Network, Toronto

Status

Enrolling

Conditions

Risk of Fracture
Cancer
Metastatic Malignant Neoplasm to Femur

Treatments

Other: Combined Surgery and Radiation therapy
Procedure: Surgery Alone

Study type

Interventional

Funder types

Other

Identifiers

NCT01428895
OCREB 09-004

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

180 participants in 2 patient groups

Surgery Alone
Active Comparator group
Treatment:
Procedure: Surgery Alone
Surgery + Radiation Therapy
Active Comparator group
Treatment:
Other: Combined Surgery and Radiation therapy

Trial contacts and locations

2

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Central trial contact

Rebecca Wong, MB ChB

Data sourced from clinicaltrials.gov

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