Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia

Last updated: October 14, 2021
Sponsor: Vancouver Coastal Health Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pelvic Cancer

Endometriosis

Endometrial Hyperplasia

Treatment

N/A

Clinical Study ID

NCT04362046
H17-00780
  • Ages 19-39
  • Female

Study 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.

Eligibility Criteria

Inclusion

All candidates for this protocol must have an adequate trial of anti-hormone therapy priorto hysteroscopic resection. In cases of EC, the minimum trial is 6 months of high-doseprogestin. In cases of AH, being that this is a benign condition (pre-malignant), patientsmay not require a full 6 months of anti-hormone therapy. All patients must have a pre-HRhysteroscopic evaluation to confirm that they are suitable candidates for this study.Patients being considered for the experimental intervention (hysteroscopic resection) willbe reviewed and discussed by the study committee in order to ensure that the followingcriterion 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 theendometrial 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

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 theassessment of the hysteroscopic surgery success rates.
  • Significant underlying fertility impairment that would significantly interfere withthe success rate of HR

Study Design

Total Participants: 30
Study Start date:
November 15, 2020
Estimated Completion Date:
July 31, 2028

Study 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.

Connect with a study center

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

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