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Procedure
Bariatric Surgery for Endometrial Cancer (B-FiERCE Trial)
N/A
Recruiting
Led By Sarah E Ferguson, MD
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
ECOG status <2
Clinical stage 1 disease - no evidence of metastatic disease beyond the uterus by physical exam or imaging performed (MRI, CT)
Must not have
Evidence of myometrial invasion or extra-uterine disease on imaging
Medical co-morbidity with end-organ dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 3
Awards & highlights
No Placebo-Only Group
Summary
This trial suggests that bariatric surgery in addition to progestin may improve outcomes for young women with obesity-related endometrial cancer/atypical hyperplasia.
Who is the study for?
This trial is for young women with obesity who have early-stage endometrial cancer or atypical hyperplasia, want to preserve their fertility, and have a BMI ≥ 35. They should not be pregnant, have no history of certain cancers or major upper abdominal surgery (except some procedures like appendectomy), and must understand the consent process.
What is being tested?
The study tests if bariatric surgery combined with progestin therapy can help achieve significant weight loss and improve treatment response in obese women with early-stage endometrial cancer/atypical hyperplasia wishing to maintain fertility.
What are the potential side effects?
Potential side effects include those related to bariatric surgery such as nutritional deficiencies, digestive issues, surgical complications; plus any associated with progestin IUD use like pelvic pain, irregular bleeding or hormonal changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do all my daily activities without help.
Select...
My cancer is in stage 1 and has not spread beyond the uterus.
Select...
I have been diagnosed with a specific type of early-stage uterine cancer or pre-cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer has spread beyond the uterus, as shown by scans.
Select...
I have a health condition that affects how my organs work.
Select...
I am currently taking medication to lose weight.
Select...
I am able to understand and participate in the informed consent process.
Select...
My endometrial cancer is high grade or has p53 abnormalities.
Select...
I cannot have sleeve gastrectomy due to health reasons.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 3
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recruitment Rate
Secondary study objectives
Complete Response Rate
Completion of Bariatric Surgery
Completion of Patient Reported Outcome Questionnaires
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bariatric Surgery and Progestin Intrauterine DeviceExperimental Treatment1 Intervention
This group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.
Group II: Progestin Intrauterine Device AloneActive Control1 Intervention
This group will receive a progestin intrauterine device alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bariatric Surgery
2016
Completed Phase 3
~14180
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,523 Previous Clinical Trials
503,162 Total Patients Enrolled
1 Trials studying Bariatric Surgery Candidates
140 Patients Enrolled for Bariatric Surgery Candidates
Sarah E Ferguson, MDPrincipal InvestigatorUniversity Health Network, Toronto
1 Previous Clinical Trials
108 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread beyond the uterus, as shown by scans.I had cancer before, but it was cured and I've been cancer-free for over 5 years.Your body mass index (BMI) is 35 or higher.I have a health condition that affects how my organs work.I can do all my daily activities without help.I am currently taking medication to lose weight.My cancer is in stage 1 and has not spread beyond the uterus.I am able to understand and participate in the informed consent process.I want to preserve my ability to have children.My endometrial cancer is high grade or has p53 abnormalities.I cannot have sleeve gastrectomy due to health reasons.I have been diagnosed with a specific type of early-stage uterine cancer or pre-cancer.I have had major surgery in my upper abdomen, but not minor procedures like appendix removal.
Research Study Groups:
This trial has the following groups:- Group 1: Bariatric Surgery and Progestin Intrauterine Device
- Group 2: Progestin Intrauterine Device 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.
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