Clinical trial NCT04290299: Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive
Official title: Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrial Cancer
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premenopausal women diagnosed with endometrial cancer (EC)

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.

Detailed description: 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Proportion of complete regression
timeFrame: 10 years
measure: Duration of response
timeFrame: 10 years
measure: Frequency of relapse
timeFrame: 10 years
measure: Pattern of relapse
timeFrame: 10 years
measure: Frequency of metachronous ovarian cancer
timeFrame: 10 years
measure: Tumor-related deaths
timeFrame: 10 years
Secondary outcomes:
measure: Treatment related morbidity
timeFrame: 10 years
measure: Frequency of spontaneous pregnancies
timeFrame: 10 years
measure: Frequency of pregnancies after ART
timeFrame: 10 years
measure: Frequency of residual disease on definitive surgical specimens
timeFrame: 10 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Cooperative Ovarian Cancer Group (COGI)
state: California
city: Sydney
country: Australia
facility: ANZGOG - Australia and New Zealand Gynecological Oncology Group
city: Vienna
country: Austria
facility: AGO-AUST Arbeitsgemeinschaft Gynaekologische Onkologie
city: Brussels
country: Belgium
facility: EORTC - European Organization for Research and Treatment of Cancer
city: Ottawa
country: Canada
facility: NCIC Clinical Trials Group (Canadian Cancer Society Research Institute)
city: Toronto
country: Canada
facility: PMHC (Princess Margaret Hospital Consortium)
city: Shangai
country: China
facility: SGOG (Shanghai Gynecologic Oncology Group)
city: Copenhagen
country: Denmark
facility: NSGO (Nordic Society of Gynecologic Oncology)
city: Paris
country: France
facility: GINECO - Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens
city: Berlin
country: Germany
facility: AGO-De Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom
city: Berlin
country: Germany
facility: NOGGO (Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie)
city: Dublin
country: Ireland
facility: ICORG - Ireland Cooperative Oncology Research Group
city: Naples
country: Italy
facility: MITO (Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies)
city: Katō
country: Japan
facility: GOTIC - Gynecologic Oncology Trial and Investigation Consortium
city: Tokyo
country: Japan
facility: JGOG - Japanese Gynecologic Oncology Group
city: Seul
country: Korea, Republic of
facility: KGOG - Korean Gynecologic Oncology Group
city: Amsterdam
country: Netherlands
facility: DGOG - Dutch Gynecologic Oncology Group
city: Madrid
country: Spain
facility: GEICO - Grupo Espanol de Investigacion en Cancer de Ovario
city: Edinburgh
country: United Kingdom
facility: SGCTG (Scottish Gynaecological Cancer Trials Group)
Study officials:
affiliation: National Cancer Institute of Naples
name: Stefano Greggi, MD
role: PRINCIPAL_INVESTIGATOR
References: