Fertility preservation for women with endometrial cancer and hyperplasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of hysteroscopic endomyometrial resection in women diagnosed with atypical endometrial hyperplasia or grade I endometrial cancer who have not responded to anti-hormone therapy. The aim is to provide a fertility-sparing treatment option for younger women who face the prospect of hysterectomy. The approach involves a multidisciplinary team and closely monitors patients to ensure safety and efficacy. The hypothesis is that hysteroscopic resection can be a viable alternative to traditional surgical methods for these conditions.

Why it matters

Who can join: the full rules

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

Where it's running

• Vancouver General Hospital
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Mark Carey, MD — Vancouver Coastal Health
• Study coordinator: Neeraj Mehra, MD
• Email: neeraj.mehra@ubc.ca
• Phone: 604-875-5508

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.