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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To describe the ambulatory status at 3 months by intervention (surgery ± radiotherapy, and radiotherapy alone group) - Ambulatory status

Secondary study objectives

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