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Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia (FETCH)

Primary Purpose

Endometrial Hyperplasia, Endometrial Cancer, Gynecologic Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hysteroscopic uterine resection
Sponsored by
Vancouver Coastal Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Hyperplasia focused on measuring Fertility preservation, Hysteroscopic uterine resection, High-dose progesterone

Eligibility Criteria

19 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Vancouver General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hysteroscopic uterine resection

Arm Description

This is a prospective single-arm surgical intervention trial.

Outcomes

Primary Outcome Measures

Conception rate of women attempting pregnancy
live births / women attempting pregnancy
Overall conception rate
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)
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)
patients developing distant recurrence / patients treated with hysteroscopic resection

Secondary Outcome Measures

Complications/side-effects
The investigators will tabulate complications/side-effects of the procedure such as the rate of uterine perforation, uterine adhesion, procedure infection, and others.

Full Information

First Posted
April 22, 2020
Last Updated
October 14, 2021
Sponsor
Vancouver Coastal Health Research Institute
Collaborators
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04362046
Brief Title
Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia
Acronym
FETCH
Official Title
Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage 1A, Endometrial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
July 2028 (Anticipated)
Study Completion Date
July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vancouver Coastal Health Research Institute
Collaborators
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Hyperplasia, Endometrial Cancer, Gynecologic Cancer
Keywords
Fertility preservation, Hysteroscopic uterine resection, High-dose progesterone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hysteroscopic uterine resection
Arm Type
Experimental
Arm Description
This is a prospective single-arm surgical intervention trial.
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopic uterine resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Conception rate of women attempting pregnancy
Description
live births / women attempting pregnancy
Time Frame
3 years post-resection
Title
Overall conception rate
Description
live births / all women participating in study, including those who failed hysteroscopic resection and have a hysterectomy
Time Frame
3 years post-resection
Title
Local disease control rate (short-term failure of hysteroscopic resection)
Description
Patients with persisting atypical hyperplasia or Grade I endometrial cancer / patients treated with hysteroscopic resection
Time Frame
3 months post-resection
Title
Distant disease control rate (long-term failure of hysteroscopic resection)
Description
patients developing distant recurrence / patients treated with hysteroscopic resection
Time Frame
3 years post-resection
Secondary Outcome Measure Information:
Title
Complications/side-effects
Description
The investigators will tabulate complications/side-effects of the procedure such as the rate of uterine perforation, uterine adhesion, procedure infection, and others.
Time Frame
3 years post-resection

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study being conducted on women who have Grade 1 endometrial cancer or atypical endometrial hyperplasia
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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 (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: Grade I endometrial endometrioid adrenocarcinoma (EC) with less than 1/3 of the endometrial surface involved. 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: Medroxyprogesterone acetate (Provera; 200mg/day) Megestrol acetate (Megace; 160mg/day) Adequate duration: 6 months Failure of progestin therapy defined as: Unsuccessful eradication of hyperplasia or cancer in the uterus 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neeraj Mehra, MD
Phone
604-875-5508
Email
neeraj.mehra@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Carey, MD
Organizational Affiliation
Vancouver Coastal Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janice Kwon, MD
Phone
604-875-4268
Email
janice.kwon@vch.ca
First Name & Middle Initial & Last Name & Degree
Neeraj Mehra, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The information in database/registry is anonymized. Inadvertent disclosure of the data poses no risk to patients.

Learn more about this trial

Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia

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