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Endometrial CancerB-FiERCENCT04008563

Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium

A study testing Bariatric Surgery in people with Endometrial Cancer and Atypical Hyperplasia, run by University Health Network, Toronto at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 41 years, women only
What is being tested?
Bariatric Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteCanada
Study dates
14 May 2021to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 41 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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 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

Who cannot join

  • 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
  • Previous major upper abdominal surgery (ex. previous bariatric surgery, 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. NB: patients taking glucagon-like peptide 1 (GLP-1) agonists (e.g., OZEMPIC) for the treatment of diabetes will not be excluded.
  • Contraindications to sleeve gastrectomy
Show all 12Show fewer
  • Medical co-morbidity with end-organ dysfunction
  • Unable to understand and participate in the informed consent process
  • Currently pregnant
  • Active smoking in ≤6 months
  • Active substance use disorder
  • Current untreated or severe psychiatric issue

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tara Zad contact

416-946-4501 ext. 3165

Tara.Zad@uhn.ca

Canada1 site, 1 recruiting

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2C4

    Recruiting

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Bariatric Surgery
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bariatric SurgeryProcedure or surgery

    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.

Study groups in NCT04008563
Study groupRoleWhat they receive
Bariatric Surgery and Progestin Intrauterine DeviceExperimentalThis group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.
Receives: Procedure: Bariatric Surgery
Progestin Intrauterine Device AloneNo interventionThis group will receive a progestin intrauterine device alone.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Year 5

Secondary outcomes (4)

  1. Completion of Bariatric Surgery

    Proportion of patients who complete bariatric surgery within 3-4 months (-2/+ 4 weeks) of randomization. A rate of >85% will be considered feasible.

    Measured: Year 5

  2. 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.

    Measured: Year 6

  3. 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.

    Measured: Year 5

  4. 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.

    Measured: Year 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start14 May 2021
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04008563
Sponsor's protocol ID
19-5487
Acronym
B-FiERCE
Status last verified
Mar 2025
First submitted
3 Jul 2019
Last updated
14 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Agnew H, Kitson S, Crosbie EJ. Interventions for weight reduction in obesity to improve survival in women with endometrial cancer. Cochrane Database Syst Rev. 2023 Mar 27;3(3):CD012513. doi: 10.1002/14651858.CD012513.pub3.

    PubMed 36971688

Questions about this trial

What is this clinical trial studying?

A study testing Bariatric Surgery in people with Endometrial Cancer and Atypical Hyperplasia, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tara Zad (416-946-4501 ext. 3165, Tara.Zad@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: Year 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04008563, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.

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