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.

Study Overview

• Status: Recruiting
• Conditions: Endometrial Cancer
• Intervention / Treatment: Other: Data collection

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Stefano Greggi, MD; Phone Number: +39.081.5903417; Email: s.greggi@istitutotumori.na.it
• Study Contact Backup: Name: Francesca Falcone, MD; Phone Number: +39.081.5903417; Email: francesca.falcone@istitutotumori.na.it

Study Locations

• Australia
  • Sydney, Australia
    • Recruiting
    • ANZGOG - Australia and New Zealand Gynecological Oncology Group
• Austria
  • Vienna, Austria
    • Recruiting
    • AGO-AUST Arbeitsgemeinschaft Gynaekologische Onkologie
• Belgium
  • Brussels, Belgium
    • Recruiting
    • EORTC - European Organization for Research and Treatment of Cancer
• Canada
  • Ottawa, Canada
    • Recruiting
    • NCIC Clinical Trials Group (Canadian Cancer Society Research Institute)
  • Toronto, Canada
    • Recruiting
    • PMHC (Princess Margaret Hospital Consortium)
• China
  • Shangai, China
    • Recruiting
    • SGOG (Shanghai Gynecologic Oncology Group)
• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • NSGO (Nordic Society of Gynecologic Oncology)
• France
  • Paris, France
    • Recruiting
    • GINECO - Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens
• Germany
  • Berlin, Germany
    • Recruiting
    • AGO-De Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom
  • Berlin, Germany
    • Recruiting
    • NOGGO (Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie)
• Ireland
  • Dublin, Ireland
    • Recruiting
    • ICORG - Ireland Cooperative Oncology Research Group
• Italy
  • Naples, Italy
    • Recruiting
    • MITO (Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies)
    • Contact: Stefano Greggi, MD; Email: s.greggi@istitutotumori.na.it
• Japan
  • Katō, Japan
    • Recruiting
    • GOTIC - Gynecologic Oncology Trial and Investigation Consortium
  • Tokyo, Japan
    • Recruiting
    • JGOG - Japanese Gynecologic Oncology Group
• Korea, Republic of
  • Seul, Korea, Republic of
    • Recruiting
    • KGOG - Korean Gynecologic Oncology Group
• Netherlands
  • Amsterdam, Netherlands
    • Recruiting
    • DGOG - Dutch Gynecologic Oncology Group
• Spain
  • Madrid, Spain
    • Recruiting
    • GEICO - Grupo Espanol de Investigacion en Cancer de Ovario
• United Kingdom
  • Edinburgh, United Kingdom
    • Recruiting
    • SGCTG (Scottish Gynaecological Cancer Trials Group)
• United States
  • California
    • Stanford, California, United States
      • Recruiting
      • Cooperative Ovarian Cancer Group (COGI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Premenopausal women diagnosed with endometrial cancer (EC)

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:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of response	10 years
Pattern of relapse	10 years
Proportion of complete regression	10 years
Frequency of relapse	10 years
Frequency of metachronous ovarian cancer	10 years
Tumor-related deaths	10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment related morbidity	10 years
Frequency of spontaneous pregnancies	10 years
Frequency of pregnancies after ART	10 years
Frequency of residual disease on definitive surgical specimens	10 years

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples
• Investigators: Principal Investigator: Stefano Greggi, MD, National Cancer Institute of Naples

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2015
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): April 8, 2025

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): February 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: 13/15 oss

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data generated are property of all investigators and will be object of publication after general agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No