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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 3
Awards & highlights
B-FiERCE Trial 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.Check my eligibility
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.See study design
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.
B-FiERCE Trial 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.
B-FiERCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recruitment Rate
Secondary outcome measures
Complete Response Rate
Completion of Bariatric Surgery
Completion of Patient Reported Outcome Questionnaires
+1 moreB-FiERCE 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
1,471 Previous Clinical Trials
484,934 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
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the highest capacity of subjects enrolled in this experiment?
"Affirmative. According to clinicaltrials.gov, this trial is currently recruiting; it was initially posted on August 1st 2020 and updated most recently on April 16th 2023. A total of 36 patients are needed across one medical centre for the study's completion."
Answered by AI
Who is eligible to join this clinical experiment?
"Eligible patients for this medical trial are between 18 and 41, have been identified as bariatric surgery candidates, and must be one of the 36 individuals selected to participate."
Answered by AI
Is this clinical trial open to individuals below the age of fifty?
"The age cap for enrollment in this trial is 41 years old. For patients under 18, there are 45 clinical trials they can consider; conversely, those over 65 have access to 437 different studies."
Answered by AI
Are any more individuals being recruited for this clinical experiment currently?
"Affirmative. According to clinicaltrials.gov, this experiment is still recruiting volunteers who wish to participate; it was posted on August 1st 2020 and modified as recently as April 16th 2023. At present, 36 participants are needed from a single medical site."
Answered by AI
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