Femoral Bone Metastases
This study is currently recruiting participants.
Verified December 2012 by University Health Network, Toronto
Sponsor:
University Health Network, Toronto
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01428895
First received: May 19, 2011
Last updated: December 13, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer Metastatic Malignant Neoplasm to Femur Risk of Fracture |
Procedure: Surgery Alone Other: Combined Surgery and Radiation therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
| 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 |
Resource links provided by NLM:
Further study details as provided by University Health Network, Toronto:
Primary Outcome Measures:
- To describe the ambulatory status at 3 months by intervention (surgery ± radiotherapy, and radiotherapy alone group) - Ambulatory status [ Time Frame: 6 months ] [ Designated as safety issue: No ]Patient will be assessed at baseline, 6 weeks, 3 months and 6 months
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Patients will be assessed at baseline, 6 weeks, 3 months and 6 months
- 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 ] [ Designated as safety issue: No ]Patient will be assessed at baseline, 6 weeks, 3 months, and 6 months.
| Estimated Enrollment: | 180 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Surgery Alone |
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.
|
| Active Comparator: Surgery + Radiation Therapy |
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428895
Contacts
| Contact: Rebecca Wong, MB ChB | 416 946 4501 ext 2126 | Rebecca.wong@rmp.uhn.on.ca |
Locations
| Canada, Ontario | |
| University Health Network, Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Rebecca Wong, MB ChB 416 946 4501 ext 2126 Rebecca.Wong@rmp.uhn.on.ca | |
| Mount Sinai Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Contact: Peter Ferguson, MD 416 586-4800 ext 8687 PFerguson@mtsinai.on.ca | |
Sponsors and Collaborators
University Health Network, Toronto
Investigators
| Principal Investigator: | Rebecca Wong, MB ChB | University Health Network, Princess Margaret Hospital |
| Principal Investigator: | Peter Ferguson, MD | Mount Sinai Hospital, Toronto |
More Information
No publications provided
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01428895 History of Changes |
| Other Study ID Numbers: | OCREB 09-004 |
| Study First Received: | May 19, 2011 |
| Last Updated: | December 13, 2012 |
| Health Authority: | Canada: Research Ethics Committee |
Keywords provided by University Health Network, Toronto:
|
Bone Metastases Femoral Metastases |
Additional relevant MeSH terms:
|
Neoplasms Fractures, Bone Fractures, Spontaneous Neoplasm Metastasis Bone Neoplasms Bone Marrow Diseases Neoplasms, Second Primary |
Wounds and Injuries Neoplastic Processes Pathologic Processes Neoplasms by Site Bone Diseases Musculoskeletal Diseases Hematologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013