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Surgery Alone vs Surgery + Radiation for Bone Cancer

N/A
Recruiting
Led By Rebecca Wong, MB ChB
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will help researchers understand how best to treat femoral metastases, specifically those at high risk of pathological fracture.

Who is the study for?
This trial is for adults with a confirmed cancer diagnosis, who have bone metastases in the femur at high risk of breaking (Mirels' score ≥8). Participants must be able to give consent and commit to follow-up. It's not suitable for individuals with lymphoma or those unable to participate.Check my eligibility
What is being tested?
The study compares two approaches for treating patients with high-risk femoral bone metastases: one group will receive surgery followed by radiation therapy, while another group will undergo surgery alone. The focus is on pain relief, mobility, limb function, and life quality after treatment.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks like infection or bleeding and radiation-related issues such as skin irritation or fatigue. Pain levels might fluctuate during recovery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To describe the ambulatory status at 3 months by intervention (surgery ± radiotherapy, and radiotherapy alone group) - Ambulatory status
Secondary outcome measures
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
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

Trial Design

2Treatment groups
Active Control
Group I: Surgery + Radiation TherapyActive Control1 Intervention
Group II: Surgery AloneActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,483 Previous Clinical Trials
486,237 Total Patients Enrolled
Rebecca Wong, MB ChBPrincipal InvestigatorUniversity Health Network, Princess Margaret Hospital
Peter Ferguson, MDPrincipal InvestigatorMount Sinai Hospital, Canada
2 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Combined Surgery and Radiation therapy Clinical Trial Eligibility Overview. Trial Name: NCT01428895 — N/A
Bone Cancer Research Study Groups: Surgery + Radiation Therapy, Surgery Alone
Bone Cancer Clinical Trial 2023: Combined Surgery and Radiation therapy Highlights & Side Effects. Trial Name: NCT01428895 — N/A
Combined Surgery and Radiation therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01428895 — N/A
~11 spots leftby Jun 2025
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