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Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive

NCT04290299 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-10-13

No results posted yet for this study

Summary

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

Interventions

OTHER

Data collection

Cancer (response, relapse) and fertility (pregnancy, delivery) outcomes

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Stefano Greggi, MD · National Cancer Institute of Naples

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-15
Primary Completion
2025-02-01
Completion
2025-04-08

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • China
  • Denmark
  • France
  • Germany
  • Ireland
  • Italy
  • Japan
  • Netherlands
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04290299 on ClinicalTrials.gov