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Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia (FETCH)

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ClinicalTrials.gov Identifier: NCT04362046
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : October 20, 2021
Sponsor:
Collaborator:
University of British Columbia
Information provided by (Responsible Party):
Mark Carey, Vancouver Coastal Health Research Institute

Tracking Information
First Submitted Date  ICMJE April 22, 2020
First Posted Date  ICMJE April 24, 2020
Last Update Posted Date October 20, 2021
Actual Study Start Date  ICMJE November 15, 2020
Estimated Primary Completion Date July 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2020)
  • Conception rate of women attempting pregnancy [ Time Frame: 3 years post-resection ]
    live births / women attempting pregnancy
  • Overall conception rate [ Time Frame: 3 years post-resection ]
    live births / all women participating in study, including those who failed hysteroscopic resection and have a hysterectomy
  • Local disease control rate (short-term failure of hysteroscopic resection) [ Time Frame: 3 months post-resection ]
    Patients with persisting atypical hyperplasia or Grade I endometrial cancer / patients treated with hysteroscopic resection
  • Distant disease control rate (long-term failure of hysteroscopic resection) [ Time Frame: 3 years post-resection ]
    patients developing distant recurrence / patients treated with hysteroscopic resection
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2021)
Complications/side-effects [ Time Frame: 3 years post-resection ]
The investigators will tabulate complications/side-effects of the procedure such as the rate of uterine perforation, uterine adhesion, procedure infection, and others.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2020)
Complications/side-effects [ Time Frame: 3 years post-resection ]
We will tabulate complications/side-effects of the procedure such as the rate of uterine perforation, uterine adhesion, procedure infection, and others.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia
Official Title  ICMJE Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage 1A, Endometrial Cancer
Brief Summary This study protocol evaluates the use of hysteroscopic endomyometrial resection in women diagnosed with atypical endometrial hyperplasia or grade I endometrial cancer who have not responded to anti-hormone therapy. Patients in this study wish to preserve fertility.
Detailed Description Endometrial cancer (EC) is the most common gynecological cancer among Canadian women. This cancer often arises from a precursor lesion called atypical endometrial hyperplasia (AH). Hysterectomy is the most effective treatment for EC and AH. It is well recognized that EC may be diagnosed in younger women of child-bearing age. The diagnosis of EC or AH in these younger women is devastating as a hysterectomy is frequently required. Though some of these women respond to high-dose progestin treatment, the failure rate is high (60%), necessitating surgery. Recent case series show that some women with AH and early EC can be treated by resecting the precursor lesion of the early cancerous area in the uterus by hysteroscopy without the need for hysterectomy. The fertility-sparing approach is outlined in this research protocol.This is a multidisciplinary research project with input from gynaecologic oncology, general gynaecology, reproductive endocrinology and infertility, and pathology. Our hypothesis is that hysteroscopic resection (HR) is a safe and effective treatment for AH or EC in women who want to preserve their fertility and have not been successfully treated using progestin therapy. Patients will be closely monitored to ensure that this is a safe and effective treatment option.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometrial Hyperplasia
  • Endometrial Cancer
  • Gynecologic Cancer
Intervention  ICMJE Procedure: Hysteroscopic uterine resection

Hysteroscopic Resection will be evaluated as a fertility-sparing treatment for patients with early Endometrial Cancer or Endometrial Hyperplasia (atypical or persisting typical) who fail progestin therapy. Failure of progesterone therapy is defined as: (a) Unsuccessful eradication of hyperplasia or cancer in the uterus or (b) Intolerance to the side effects of th hormone therapy.

HR is a common gynecologic procedure that is offered to women for treatment of several benign gynecologic conditions. The conduct, risks, and complications of it are well-understood. In relation to this protocol, it is the indication for HR that constitutes the experimental intervention including the assessment of it's outcome. Patients deemed appropriate for hysteroscopic endomyometrial resection will be counselled on the nature of the procedure along with its risks and complications.

Study Arms  ICMJE Experimental: Hysteroscopic uterine resection
This is a prospective single-arm surgical intervention trial.
Intervention: Procedure: Hysteroscopic uterine resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2028
Estimated Primary Completion Date July 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

All candidates for this protocol must have an adequate trial of anti-hormone therapy prior to hysteroscopic resection. In cases of EC, the minimum trial is 6 months of high-dose progestin. In cases of AH, being that this is a benign condition (pre-malignant), patients may not require a full 6 months of anti-hormone therapy. All patients must have a pre-HR hysteroscopic evaluation to confirm that they are suitable candidates for this study. Patients being considered for the experimental intervention (hysteroscopic resection) will be reviewed and discussed by the study committee in order to ensure that the following criterion are met in order to proceed with the surgical resection:

Inclusion criteria:

  • Age less than 40 years
  • Pathologist confirmed biopsy evidence of one of the following:

    1. Grade I endometrial endometrioid adrenocarcinoma (EC) with less than 1/3 of the endometrial surface involved.
    2. Atypical endometrial hyperplasia (AH)
  • MRI demonstrating less than 1/3 myometrial invasion if the patient has EC
  • Absence of significant surgical co-morbidities e.g. pulmonary hypertension, significant cardiac valvular disease, or contraindication to surgery.
  • Desire to preserve fertility
  • Reasonable chance to conceive based on consultation with an infertility specialist
  • Adequate dose and duration of progesterone therapy prior to enrolment:
  • Adequate dose:

    1. Medroxyprogesterone acetate (Provera; 200mg/day)
    2. Megestrol acetate (Megace; 160mg/day)
  • Adequate duration: 6 months
  • Failure of progestin therapy defined as:

    1. Unsuccessful eradication of hyperplasia or cancer in the uterus
    2. Intolerance to the side effects
  • Signed informed consent

Exclusion criteria:

  • Age 40 years and over
  • Grade 2 or 3 endometrioid endometrial adenocarcinoma or non-endometrioid pathology
  • Greater than 1/3 involvement of the endometrial surface in patients with Grade I EC
  • Women who are not able to provide informed consent
  • Women without pathologic confirmation of low-grade endometrioid carcinoma or AH
  • Myometrial invasion on MRI greater than 1/3 total myometrial thickness.
  • MRI evidence of ovarian or adnexal involvement
  • The diagnosis of another cancer or medical condition that would interfere with the assessment of the hysteroscopic surgery success rates.
  • Significant underlying fertility impairment that would significantly interfere with the success rate of HR
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: This study being conducted on women who have Grade 1 endometrial cancer or atypical endometrial hyperplasia
Ages  ICMJE 19 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Neeraj Mehra, MD 604-875-5508 neeraj.mehra@ubc.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04362046
Other Study ID Numbers  ICMJE H17-00780
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The information in database/registry is anonymized. Inadvertent disclosure of the data poses no risk to patients.
Current Responsible Party Mark Carey, Vancouver Coastal Health Research Institute
Original Responsible Party Mark Carey, Vancouver Coastal Health Research Institute, Dr
Current Study Sponsor  ICMJE Vancouver Coastal Health Research Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of British Columbia
Investigators  ICMJE
Principal Investigator: Mark Carey, MD Vancouver Coastal Health
PRS Account Vancouver Coastal Health Research Institute
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP