Fertility preservation for women with endometrial cancer and hyperplasia
Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage 1A, Endometrial Cancer
This study is testing a new surgery to help younger women with early-stage endometrial cancer or hyperplasia keep their ability to have children instead of needing a hysterectomy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years to 39 Years |
| Sex | Female |
| Sponsor | Vancouver Coastal Health Research Institute Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT04362046 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women under 40 years old with confirmed atypical endometrial hyperplasia or grade I endometrial cancer who have previously undergone anti-hormone therapy.
Not a fit: Patients with advanced endometrial cancer or those who do not wish to preserve their fertility may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could allow women with early-stage endometrial cancer or hyperplasia to preserve their fertility while effectively managing their condition.
How similar studies have performed: Other studies have shown promising results with similar fertility-sparing approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vancouver, British Columbia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.