Recruiting

Endometrial Cancer

Sponsor:

National Cancer Institute, Naples

Code:

NCT04290299

Conditions

Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Data collection

Study Details

Brief 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

Endometrial Cancer

Study ID

NCT04290299

Start date

Sep 15, 2015

Status verified date

Oct, 2021

Completion date

Apr 8, 2025

Anticipated

Primary completion date

Feb 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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:

-

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

Data collection

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

Primary outcome measure

  • Proportion of complete regression [ Time Frame: 10 years ]
  • Duration of response [ Time Frame: 10 years ]
  • Frequency of relapse [ Time Frame: 10 years ]
  • Pattern of relapse [ Time Frame: 10 years ]
  • Frequency of metachronous ovarian cancer [ Time Frame: 10 years ]
  • Tumor-related deaths [ Time Frame: 10 years ]

Central Contacts and Locations

Locations

Cooperative Ovarian Cancer Group (COGI)

Recruiting

Stanford, California, United States

NCIC Clinical Trials Group (Canadian Cancer Society Research Institute)

Recruiting

Ottawa, Canada

PMHC (Princess Margaret Hospital Consortium)

Recruiting

Toronto, Canada

More Information

Sponsor

National Cancer Institute, Naples

Last update posted

Oct 13, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute, Naples on 2021-10-13.