Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive
Approximately one fourth of cases of endometrial cancer (EC) are diagnosed in premenopausal women, of whom approximately 40% wish to preserve their fertility. When arising in young women, EC usually presents with favorable prognostic features, as a focal, well differentiated endometrioid tumor, with minimal or absent myometrial invasion. This profile corresponds to the Type 1 EC, which correlates with the estrogen/progesterone receptor positive (ER+/PR+) pattern. On the other hand, these patients frequently present with clinical signs of a hyperestrogenism (chronic anovulation, infertility, obesity). Primary progestin therapy has been demonstrated to be effective in early well differentiated tumors and in poor operative candidates with response rates ranging from 58-100%.Currently, the therapeutic approach to an early stage EC consists of a staging laparotomy/laparoscopy, including a total abdominal hysterectomy and bilateral salpingo-oophorectomy (TAH-BSO), peritoneal washings, and lymphadenectomy (pelvic and aortic), depending on the pathological risk profile pre- and intraoperatively determined. Therefore, the current standard of surgical approach is preclusive of fertility.
The worldwide experience and data on conservative management of EC are, however, still limited. Most of reports based on cases retrospectively collected, harboring potential methodological bias, using different treatments and drugs, and with insufficient follow-up.
Some systematic reviews have been published in the last decade, trying to summarize the literature data. Therapeutic results seem to be promising with a regression rate of approximately 75% and relapse occurring in 25-40% of cases, with anecdotical reports of deaths of disease (DOD). The fertility outcome was, however, not satisfying with about 30% pregnancy rate in patients attempting to conceive, and an overall low rate of assisted reproductive techniques (ART) despite the subfertile clinical profile.Therefore, there is a need for a prospective, multicentre cooperative project able to systematically collect data from consecutive patients treated according to defined (not necessarily identical) protocols, concerning the oncological, as well as, the obstetrical outcomes. Moreover, this project could represent the "template" in which a pretreatment fertility counseling, psychological support, and definitive surgery are routinely included according to shared criteria.
Conditions:
π¦ Endometrial Cancer
ποΈ Study Start (Actual)
15 September 2015
ποΈ Primary Completion (Estimated)
1 February 2025
β
Study Completion (Estimated)
8 April 2025
π₯ Enrollment (Estimated)
100
π¬ Study Type
OBSERVATIONAL
π Phase
N/A
Locations:
π
Stanford, California, United States
π
Sydney, Australia
π
Vienna, Austria
π
Brussels, Belgium
π
Ottawa, Canada
π
Toronto, Canada
π
Shangai, China
π
Copenhagen, Denmark
π
Paris, France
π
Berlin, Germany
π
Berlin, Germany
π
Dublin, Ireland
π
Naples, Italy
π
KatΕ, Japan
π
Tokyo, Japan
π
Seul, Korea, Republic of
π
Amsterdam, Netherlands
π
Madrid, Spain
π
Edinburgh, United Kingdom
More locations available...
Description
Inclusion Criteria:
- * Informed consent to personal data processing
- * Existence of an IRB-approved local protocol that allows conservative treatment to be performed or statement that such treatment is considered as a standard (please note that such protocols should be shared with the database owner National Cancer Institute of Naples).
Exclusion Criteria:
Ages Eligible for Study:
18 Years to 45 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
No
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported
results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before
being posted on the public website.
Study Registration Dates
- First Submitted
27 February 2020
- First Submitted that Met QC Criteria
27 February 2020
- First Posted
28 February 2020
Study Record Updates
- Last Update Submitted that Met QC Criteria
12 October 2021
- Last Update Posted
13 October 2021
- Last Verified
October 2021