Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium (B-FiERCE)
Primary Purpose
Endometrial Cancer, Atypical Hyperplasia, Bariatric Surgery Candidate
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bariatric Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Endometrial Cancer
Eligibility Criteria
Inclusion Criteria:
- BMI ≥ 35
- Diagnosis of grade 1 endometrioid endometrial cancer or complex atypical hyperplasia
- Clinical stage 1 disease - no evidence of metastatic disease beyond the uterus by physical exam or imaging performed (MRI, CT)
- ECOG status <2
- Desire for fertility preservation
- No contraindications to progestin intrauterine device (IUD)
- Have signed an approved informed consent form
Exclusion Criteria:
- Evidence of myometrial invasion or extra-uterine disease on imaging
- High grade or p53 endometrial cancer
- History of other malignancies, except if curatively treated with no evidence of disease for > 5 years
- Evidence of adenomyosis seen on MRI
- Previous major upper abdominal surgery (ex. splenectomy, partial gastrectomy, liver resection, bowel resection). *Appendectomy, cholecystectomy, hernia repair, and caesarean section are acceptable procedures for inclusion
- Current use of weight loss medication
- Contraindications to sleeve gastrectomy
- Medical co-morbidity with end-organ dysfunction
- Unable to understand and participate in the informed consent process
- Currently pregnant
Sites / Locations
- Princess Margaret HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bariatric Surgery and Progestin Intrauterine Device
Progestin Intrauterine Device Alone
Arm Description
This group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.
This group will receive a progestin intrauterine device alone.
Outcomes
Primary Outcome Measures
Recruitment Rate
To determine the proportion of eligible women who agree to participate in the study (recruitment rate). The primary outcome will be met and a full scale randomized controlled trial to assess efficacy will be conducted if ≥ 40% recruitment rate is achieved. Patients' reasons for participation or non-participation will be recorded.
Secondary Outcome Measures
Completion of Bariatric Surgery
Proportion of patients who complete bariatric surgery within 3 months of randomization. A rate of >85% will be considered feasible.
Loss to Follow-Up Rate
Loss to follow-up rate, defined as proportion of patients who do not complete 15-month assessment. A loss to follow-up rate of <20% will be considered feasible.
Completion of Patient Reported Outcome Questionnaires
Completion rate of patient reported outcomes that will be used in the full-scale randomized controlled trial. Completion of >80% of patient reported outcomes at baseline will indicate that use of these questionnaires is feasible.
Complete Response Rate
Overall complete response rate (CRR) after treatment with progestin intrauterine device (pIUD). This study is not powered to detect an improvement in CRR in the intervention vs. non-intervention group. However, the proportion of women who obtain a complete response in the pIUD alone group at 15 months will be used as the baseline CRR for this population and will be used to derive a sample size for a full-scale randomized controlled trial. We believe that this will be more accurate than using published data retrospective studies that are not specific to women with obesity. We will also collect the following data: (a) time to complete response, (b) overall recurrence rate, and (c) time to recurrence.
Full Information
NCT ID
NCT04008563
First Posted
July 3, 2019
Last Updated
September 12, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04008563
Brief Title
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
Acronym
B-FiERCE
Official Title
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A growing population of young women with obesity are developing atypical hyperplasia (pre-cancer) and endometrial cancer. Progestin is the standard treatment for women who wish to preserve fertility, but this approach does not address the underlying cause of endometrial cancer/atypical hyperplasia (obesity); thus response rates are low and recurrence rates are high. Significant weight loss by bariatric surgery, in combination with progestin therapy may result in greater and more durable response rates.
Detailed Description
The incidence of endometrial cancer is increasing at an alarming rate (2.6% per year). This trend parallels the rising rate of obesity, the most significant increasing risk factor for endometrial cancer. Young women with obesity and endometrial cancer or atypical hyperplasia who want to maintain their fertility and thus avoid hysterectomy are treated with progestin therapy, such as progestin intra-uterine device (pIUD). However, the pIUD achieves cancer regression in only 50-70% of women, and over 50% of initial responders will develop recurrence within two years. The effectiveness of the pIUD may be improved if the driver of endometrial cancer (obesity) was simultaneously addressed. Multiple epidemiologic studies have demonstrated that bariatric surgery reduces the risk of developing endometrial cancer. Our research aims to answer the question: "Is bariatric surgery in addition to the pIUD a feasible and acceptable option for young women with endometrial cancer/atypical hyperplasia who wish to maintain their childbearing potential compared to standard treatment of pIUD alone?
This is a pilot randomized controlled trial to assess the feasibility of a full-scale randomized controlled trial. Eligible women will be identified and consented over a 21-month period, and participants will be randomized to bariatric surgery plus standard pIUD (intervention group) or to standard pIUD alone (non-intervention group) in a 1:1 fashion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Atypical Hyperplasia, Bariatric Surgery Candidate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention Group: Bariatric Surgery and Progestin Intrauterine Device (pIUD) Non-Intervention Group: Progestin Intrauterine Device (pIUD) alone
Participants who consent will be randomized in a 1:1 allocation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bariatric Surgery and Progestin Intrauterine Device
Arm Type
Experimental
Arm Description
This group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.
Arm Title
Progestin Intrauterine Device Alone
Arm Type
No Intervention
Arm Description
This group will receive a progestin intrauterine device alone.
Intervention Type
Procedure
Intervention Name(s)
Bariatric Surgery
Intervention Description
Patients who are randomized to the intervention group will receive a progestin intrauterine device and be referred for bariatric service to undergo bariatric surgery within 3 months of their study consent.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
To determine the proportion of eligible women who agree to participate in the study (recruitment rate). The primary outcome will be met and a full scale randomized controlled trial to assess efficacy will be conducted if ≥ 40% recruitment rate is achieved. Patients' reasons for participation or non-participation will be recorded.
Time Frame
Year 3
Secondary Outcome Measure Information:
Title
Completion of Bariatric Surgery
Description
Proportion of patients who complete bariatric surgery within 3 months of randomization. A rate of >85% will be considered feasible.
Time Frame
Year 3
Title
Loss to Follow-Up Rate
Description
Loss to follow-up rate, defined as proportion of patients who do not complete 15-month assessment. A loss to follow-up rate of <20% will be considered feasible.
Time Frame
Year 3
Title
Completion of Patient Reported Outcome Questionnaires
Description
Completion rate of patient reported outcomes that will be used in the full-scale randomized controlled trial. Completion of >80% of patient reported outcomes at baseline will indicate that use of these questionnaires is feasible.
Time Frame
Year 3
Title
Complete Response Rate
Description
Overall complete response rate (CRR) after treatment with progestin intrauterine device (pIUD). This study is not powered to detect an improvement in CRR in the intervention vs. non-intervention group. However, the proportion of women who obtain a complete response in the pIUD alone group at 15 months will be used as the baseline CRR for this population and will be used to derive a sample size for a full-scale randomized controlled trial. We believe that this will be more accurate than using published data retrospective studies that are not specific to women with obesity. We will also collect the following data: (a) time to complete response, (b) overall recurrence rate, and (c) time to recurrence.
Time Frame
Year 3
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI ≥ 35
Diagnosis of grade 1 endometrioid endometrial cancer or complex atypical hyperplasia
Clinical stage 1 disease - no evidence of metastatic disease beyond the uterus by physical exam or imaging performed (MRI, CT)
ECOG status <2
Desire for fertility preservation
No contraindications to progestin intrauterine device (IUD)
Have signed an approved informed consent form
Exclusion Criteria:
Evidence of myometrial invasion or extra-uterine disease on imaging
High grade or p53 endometrial cancer
History of other malignancies, except if curatively treated with no evidence of disease for > 5 years
Evidence of adenomyosis seen on MRI
Previous major upper abdominal surgery (ex. splenectomy, partial gastrectomy, liver resection, bowel resection). *Appendectomy, cholecystectomy, hernia repair, and caesarean section are acceptable procedures for inclusion
Current use of weight loss medication
Contraindications to sleeve gastrectomy
Medical co-morbidity with end-organ dysfunction
Unable to understand and participate in the informed consent process
Currently pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nav Kaur
Phone
416-946-4501
Ext
3278
Email
navjot.kaur2@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah E Ferguson, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
We'll reach out to this number within 24 hrs