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

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ClinicalTrials.gov Identifier: NCT04008563
Recruitment Status : Not yet recruiting
First Posted : July 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Atypical Hyperplasia Bariatric Surgery Candidate Procedure: Bariatric Surgery Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Bariatric Surgery for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bariatric Surgery and Progestin Intrauterine Device
This group will receive a progestin intrauterine device and be offered to undergo bariatric surgery.
Procedure: Bariatric 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.

No Intervention: Progestin Intrauterine Device Alone
This group will receive a progestin intrauterine device alone.



Primary Outcome Measures :
  1. Recruitment Rate [ Time Frame: Year 3 ]
    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 :
  1. Completion of Bariatric Surgery [ Time Frame: Year 3 ]
    Proportion of patients who complete bariatric surgery within 3 months of randomization. A rate of >85% will be considered feasible.

  2. Loss to Follow-Up Rate [ Time Frame: Year 3 ]
    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.

  3. Completion of Patient Reported Outcome Questionnaires [ Time Frame: Year 3 ]
    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.

  4. Complete Response Rate [ Time Frame: Year 3 ]
    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.



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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008563


Contacts
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Contact: Gabrielle Ene 416-946-4501 ext 3969 Gabrielle.Ene@uhnresearch.ca

Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Sarah E Ferguson, MD University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04008563     History of Changes
Other Study ID Numbers: 19-5487
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Hyperplasia
Pathologic Processes
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs