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History of Changes for Study: NCT04362046
Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia (FETCH)
Latest version (submitted October 14, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 22, 2020 None (earliest Version on record)
2 October 14, 2021 Recruitment Status, Study Status, Contacts/Locations, Sponsor/Collaborators, Eligibility, Outcome Measures, Study Description, Oversight and Study Identification
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Study NCT04362046
Submitted Date:  April 22, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: H17-00780
Brief Title: Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia (FETCH)
Official Title: Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage IA, Endometrial Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2020
Overall Status: Not yet recruiting
Study Start: May 2020
Primary Completion: May 2028 [Anticipated]
Study Completion: May 2028 [Anticipated]
First Submitted: April 22, 2020
First Submitted that
Met QC Criteria:
April 22, 2020
First Posted: April 24, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 22, 2020
Last Update Posted: April 24, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Vancouver Coastal Health Research Institute
Responsible Party: Principal Investigator
Investigator: Mark Carey
Official Title: Dr
Affiliation: Vancouver Coastal Health Research Institute
Collaborators: University of British Columbia
Gynecologic Cancer Initiative - Clinical Trials Group (GCI-CTG)
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This study protocol evaluates the use of hysterscopic 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.
Open or close this module Conditions
Conditions: Endometrial Hyperplasia
Endometrial Cancer
Gynecologic Cancer
Keywords: Fertility preservation
Hysteroscopic uterine resection
High-dose progesterone
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Hysteroscopic uterine resection
This is a prospective single-arm surgical intervention trial.
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.

Open or close this module Outcome Measures
Primary Outcome Measures:
1. Conception rate of women attempting pregnancy
[ Time Frame: 3 years post-resection ]

live births / women attempting pregnancy
2. 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
3. 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
4. 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
Secondary Outcome Measures:
1. 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.
Open or close this module Eligibility
Minimum Age: 19 Years
Maximum Age: 39 Years
Sex: Female
Gender Based: Yes
This study being conducted on women who have Grade 1 endometrial cancer or atypical endometrial hyperplasia
Accepts Healthy Volunteers: No
Criteria:

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 (hysterscopic resection) will be discussed/conferenced 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. Medroxiprogesterone 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 endometroid endometrial adenocarcinoma or non-endometroid 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
Open or close this module Contacts/Locations
Central Contact Person: Neeraj Mehra, MD
Telephone: 604-875-5508
Email: neeraj.mehra@ubc.ca
Central Contact Backup: Maggie Bryce, MSc
Telephone: 604 771 1136
Email: maggie.bryce@ubc.ca
Study Officials: Mark Carey, MD
Principal Investigator
Vancouver Coastal Health
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
The information in database/registry is anonymized. Inadvertent disclosure of the data poses no risk to patients.
Open or close this module References
Citations:
Links:
Available IPD/Information:

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