Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia

NCT ID: NCT04362046

Last Updated: 2021-10-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-15
• Study Completion Date: 2028-07-31

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.

Conditions

Endometrial Hyperplasia; Endometrial Cancer; Gynecologic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hysteroscopic uterine resection

This is a prospective single-arm surgical intervention trial.

Group Type: EXPERIMENTAL

Hysteroscopic uterine resection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: collaborator

Vancouver Coastal Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Mark Carey

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Carey, MD

Role: PRINCIPAL_INVESTIGATOR

Vancouver Coastal Health

Locations

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Neeraj Mehra, MD

Role: CONTACT

neeraj.mehra@ubc.ca

604-875-5508

Facility Contacts

Janice Kwon, MD

Role: primary

janice.kwon@vch.ca

604-875-4268

Other Identifiers

H17-00780

Identifier Type: -

Identifier Source: org_study_id