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A Prospective Cohort Study of the Role of Surgery and/or Radiotherapy for Bone Metastases of the Femur at High Risk of Pathological Fracture


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer, Metastatic Malignant Neoplasm to Femur, Risk of Fracture

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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

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