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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
Histologically confirmed diagnosis of malignancy other than lymphoma
Presence of femoral metastases at high risk of pathologic fracture (Mirels' score 8 or more)
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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
1,456 Previous Clinical Trials
482,693 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
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Surgery + Radiation Therapy
- Group 2: Surgery Alone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have registered for this clinical trial?
"Absolutely. According to the clinicaltrials.gov listing, this study initiated recruitment on March 1st 2009 and has been recently updated as of October 6th 2022. This medical trial is currently requesting 180 patients for participation at two separate sites."
Answered by AI
Are new participants still eligible to join this research experiment?
"Indeed, clinicaltrials.gov confirms that this medical trial remains open to applicants. Originally posted on March 1st 2009 and updated October 6th 2022, the study is targeting 180 patients across two research centres."
Answered by AI
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