Status:
RECRUITING
Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia
Lead Sponsor:
Vancouver Coastal Health Research Institute
Collaborating Sponsors:
University of British Columbia
Conditions:
Endometrial Hyperplasia
Endometrial Cancer
Eligibility:
FEMALE
19-39 years
Phase:
NA
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-ho...
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...
Eligibility Criteria
Inclusion
- 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:
- Grade I endometrial endometrioid adrenocarcinoma (EC) with less than 1/3 of the endometrial surface involved.
- 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:
- Medroxyprogesterone acetate (Provera; 200mg/day)
- Megestrol acetate (Megace; 160mg/day)
- Adequate duration: 6 months
- Failure of progestin therapy defined as:
- Unsuccessful eradication of hyperplasia or cancer in the uterus
- 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
Exclusion
Key Trial Info
Start Date :
November 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04362046
Start Date
November 15 2020
End Date
July 1 2028
Last Update
October 20 2021
Active Locations (1)
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1
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9