- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04362046
Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia (FETCH)
Fertility Preservation Using Endomyometrial Resection for Atypical Hyperplasia and Low Grade, Stage 1A, Endometrial Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Neeraj Mehra, MD
- Phone Number: 604-875-5508
- Email: neeraj.mehra@ubc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Recruiting
- Vancouver General Hospital
-
Contact:
- Janice Kwon, MD
- Phone Number: 604-875-4268
- Email: janice.kwon@vch.ca
-
Principal Investigator:
- Neeraj Mehra, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hysteroscopic uterine resection
This is a prospective single-arm surgical intervention trial.
|
Hysteroscopic Resection will be evaluated as a fertility-sparing treatment for patients with early Endometrial Cancer or Endometrial Hyperplasia (atypical or persisting typical) who fail progestin therapy. Failure of progesterone therapy is defined as: (a) Unsuccessful eradication of hyperplasia or cancer in the uterus or (b) Intolerance to the side effects of th hormone therapy. HR is a common gynecologic procedure that is offered to women for treatment of several benign gynecologic conditions. The conduct, risks, and complications of it are well-understood. In relation to this protocol, it is the indication for HR that constitutes the experimental intervention including the assessment of it's outcome. Patients deemed appropriate for hysteroscopic endomyometrial resection will be counselled on the nature of the procedure along with its risks and complications. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conception rate of women attempting pregnancy
Time Frame: 3 years post-resection
|
live births / women attempting pregnancy
|
3 years post-resection
|
Overall conception rate
Time Frame: 3 years post-resection
|
live births / all women participating in study, including those who failed hysteroscopic resection and have a hysterectomy
|
3 years post-resection
|
Local disease control rate (short-term failure of hysteroscopic resection)
Time Frame: 3 months post-resection
|
Patients with persisting atypical hyperplasia or Grade I endometrial cancer / patients treated with hysteroscopic resection
|
3 months post-resection
|
Distant disease control rate (long-term failure of hysteroscopic resection)
Time Frame: 3 years post-resection
|
patients developing distant recurrence / patients treated with hysteroscopic resection
|
3 years post-resection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications/side-effects
Time Frame: 3 years post-resection
|
The investigators will tabulate complications/side-effects of the procedure such as the rate of uterine perforation, uterine adhesion, procedure infection, and others.
|
3 years post-resection
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mark Carey, MD, Vancouver Coastal Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H17-00780
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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