Clinical Trial 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.
PURPOSE The goal of this research project is to learn more about the safety of conservatively
treating EC and about subsequent fertility outcome.
PROJECT TYPE Observational (patient archive) - The project runs within the framework of
Gynecologic Cancer InterGroup (GCIG), thus, participating Centres must belong to one of the
qualified National groups.
PROJECT DESIGN Observational model: Cohort
TIME PERSPECTIVE Prospective
ENDPOINT CLASSIFICATION Cancer (response, relapse) and fertility (pregnancy, delivery)
outcomes
INTERVENTIONS Data collection
OUTCOME MEASURES Primary outcome measures
- Proportion of complete regression
- Duration of response
- Frequency and pattern of relapse
- Frequency of metachronous ovarian cancer
- Tumor-related deaths
Secondary outcome measures
- Treatment related morbidity
- Frequency of spontaneous pregnancies
- Frequency of pregnancies after ART
- Pattern of residual disease on definitive surgical specimens
REQUIREMENTS FOR PATIENT REGISTRATION
- 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).
TREATMENT Since this is a archive, treatment is not dictated by a protocol. However,
treatment has to be administered according to a IRB-approved local protocol (except for the
countries where conservative treatment can be given outside a IRB-approved study because
considered as a standard procedure).
DURATION A first phase of three years is planned, eventually followed by further three years.
PUBLICATION POLICY Data generated are property of all investigators and will be object of
publication after general agreement.
DATA TO BE COLLECTED
Patient enrollment and registration of data are made by appropriate eCRFs via the Clinical
Trials Unit of National Cancer Institute of Naples (Study Data Center) website through the
following steps:
1. go to http://www.usc-intnapoli.net;
2. select language;
3. click "Ask for authorization" to create your personal account;
4. fill and send the "authorization form";
5. make a screenshot of the "authorization form" and send it to
l.sparavigna@istitutotumori.na.it;
6. enter into to the system using your credentials and click on "E.C.Co.";
7. click "the join request form";
8. wait for authorization (a verification message will be sent to your email address within
24-48 h);
9. enter into to the system using your credentials and click on "E.C.Co." for patient
registration and/or updating.
