Fertility Sparing Management of EndomeTrial Cancer and Hyperplasia

NCT04362046 | Recruiting DMC

• 1 other identifier: H17-00780
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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-hormone therapy. Patients in this study wish to preserve fertility.

Conditions

Endometrial Hyperplasia; Endometrial Cancer; Gynecologic Cancer

Keywords

Fertility preservation; Hysteroscopic uterine resection; High-dose progesterone

Outcome Measures

Primary Outcomes (4)

• Conception rate of women attempting pregnancy

  live births / women attempting pregnancy

  3 years post-resection

• Overall conception rate

  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)

  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)

  patients developing distant recurrence / patients treated with hysteroscopic resection

  3 years post-resection

Secondary Outcomes (1)

• Complications/side-effects

  3 years post-resection

Study Arms (1)

Hysteroscopic uterine resection

EXPERIMENTAL

This is a prospective single-arm surgical intervention trial.

Procedure: Hysteroscopic uterine resection

Interventions

Hysteroscopic uterine resection PROCEDURE

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.

Hysteroscopic uterine resection

Eligibility Criteria

• Age: 19 Years - 39 Years
• Gender Eligibility Details: This study being conducted on women who have Grade 1 endometrial cancer or atypical endometrial hyperplasia
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vancouver Coastal Health Research Institute: lead
• University of British Columbia: collaborator

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

MeSH Terms

Conditions

Endometrial Hyperplasia; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Mark Carey, MD

  Vancouver Coastal Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neeraj Mehra, MD

CONTACT

604-875-5508; neeraj.mehra@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: November 15, 2020
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)