Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia

Launched by VANCOUVER COASTAL HEALTH RESEARCH INSTITUTE · Apr 22, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at a special type of surgery called hysteroscopic endomyometrial resection for women who have been diagnosed with atypical endometrial hyperplasia or early-stage endometrial cancer but have not responded to hormone therapy. The goal of this study is to help women who want to preserve their ability to have children while effectively treating their condition. Participants in the trial must be under 40 years old, have specific biopsy results that confirm their diagnosis, and have already tried hormone treatment for at least six months.

To be part of this study, women will first undergo a thorough evaluation to ensure they are suitable candidates for the surgery. Eligible participants can expect to receive detailed information about the procedure and support throughout the process. It's important to note that women with more advanced cancer or certain other health conditions may not qualify for this trial. Overall, this study aims to provide a promising option for women facing these challenges while still wanting to maintain their fertility.

Gender

FEMALE

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:
• • 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