Trial Information
A Prospective Cohort Study of the Role of Surgery and/or Radiotherapy for Bone Metastases of the Femur at High Risk of Pathological Fracture
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
To describe the ambulatory status at 3 months by intervention (surgery ± radiotherapy, and radiotherapy alone group) - Ambulatory status
Outcome Description:
Patient will be assessed at baseline, 6 weeks, 3 months and 6 months
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Rebecca Wong, MB ChB
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Princess Margaret Hospital
Authority:
Canada: Research Ethics Committee
Study ID:
OCREB 09-004
NCT ID:
NCT01428895
Start Date:
March 2009
Completion Date:
March 2015
Related Keywords:
- Cancer
- Metastatic Malignant Neoplasm to Femur
- Risk of Fracture
- Bone Metastases
- Femoral Metastases
- Neoplasms
- Fractures, Bone
- Fractures, Spontaneous
- Neoplasm Metastasis
- Bone Neoplasms
- Bone Marrow Diseases
- Neoplasms, Second Primary