Treatment for femoral bone metastases at high risk of fracture
A Prospective Cohort Study of the Role of Surgery and/or Radiotherapy for Bone Metastases of the Femur at High Risk of Pathological Fracture
This study is testing whether surgery alone or surgery with radiation helps people with femoral bone cancer who are at high risk of fractures feel better and improve their mobility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT01428895 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the clinical outcomes of patients with femoral metastases who are at high risk for pathological fractures. Participants will be followed after receiving either surgery alone or a combination of surgery and post-operative radiotherapy. The study will document patient and disease characteristics, as well as assess ambulatory status and limb function before treatment. Outcomes will be measured at 6 weeks, 3 months, and 6 months post-treatment to determine the effectiveness of the interventions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed malignancy and femoral metastases at high risk of fracture.
Not a fit: Patients with lymphoma or those seeking surgical consultation solely for diagnosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies and outcomes for patients with femoral bone metastases, potentially reducing pain and enhancing mobility.
How similar studies have performed: Previous studies have indicated that surgical intervention for bone metastases can lead to significant improvements in patient outcomes, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario and 1 other locations
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
- University Health Network, Princess Margaret Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Rebecca Wong, MB ChB — University Health Network, Princess Margaret Hospital
- Study coordinator: Rebecca Wong, MB ChB
- Email: Rebecca.wong@rmp.uhn.on.ca
- Phone: 416 946 4501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.