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

NCT04290299 | Unknown

• 1 other identifier: 13/15 oss
• Study Type: observational
• Target: 100
• Locations: 15 countries
• Sites: 18

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

Outcome Measures

Primary Outcomes (6)

• Proportion of complete regression

  10 years

• Duration of response

  10 years

• Frequency of relapse

  10 years

• Pattern of relapse

  10 years

• Frequency of metachronous ovarian cancer

  10 years

• Tumor-related deaths

  10 years

Secondary Outcomes (4)

• 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

Interventions

Data collection OTHER

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Premenopausal women diagnosed with endometrial cancer (EC)

You may qualify if:

• 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).

Sponsors & Collaborators

• National Cancer Institute, Naples: lead

Study Sites (19)

Cooperative Ovarian Cancer Group (COGI)

Stanford, California, United States

RECRUITING

ANZGOG - Australia and New Zealand Gynecological Oncology Group

Sydney, Australia

RECRUITING

AGO-AUST Arbeitsgemeinschaft Gynaekologische Onkologie

Vienna, Austria

RECRUITING

EORTC - European Organization for Research and Treatment of Cancer

Brussels, Belgium

RECRUITING

NCIC Clinical Trials Group (Canadian Cancer Society Research Institute)

Ottawa, Canada

RECRUITING

PMHC (Princess Margaret Hospital Consortium)

Toronto, Canada

RECRUITING

SGOG (Shanghai Gynecologic Oncology Group)

Shanghai, China

RECRUITING

NSGO (Nordic Society of Gynecologic Oncology)

Copenhagen, Denmark

RECRUITING

GINECO - Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens

Paris, France

RECRUITING

AGO-De Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom

Berlin, Germany

RECRUITING

NOGGO (Nord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie)

Berlin, Germany

RECRUITING

ICORG - Ireland Cooperative Oncology Research Group

Dublin, Ireland

RECRUITING

MITO (Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies)

Naples, Italy

RECRUITING

GOTIC - Gynecologic Oncology Trial and Investigation Consortium

Katō, Japan

RECRUITING

JGOG - Japanese Gynecologic Oncology Group

Tokyo, Japan

RECRUITING

DGOG - Dutch Gynecologic Oncology Group

Amsterdam, Netherlands

RECRUITING

KGOG - Korean Gynecologic Oncology Group

Seoul, South Korea

RECRUITING

GEICO - Grupo Espanol de Investigacion en Cancer de Ovario

Madrid, Spain

RECRUITING

SGCTG (Scottish Gynaecological Cancer Trials Group)

Edinburgh, United Kingdom

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Stefano Greggi, MD

  National Cancer Institute of Naples

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Greggi, MD

CONTACT

+39.081.5903417; s.greggi@istitutotumori.na.it

Francesca Falcone, MD

CONTACT

+39.081.5903417; francesca.falcone@istitutotumori.na.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: February 28, 2020
• Study Start: September 15, 2015
• Primary Completion: February 1, 2025
• Study Completion: April 8, 2025
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

IE (1); CA (2); IT (1); BE (1); JP (2); US (1); FR (1); DK (1); AU (1); KR (1); ES (1); NL (1); DE (2); CN (1); GB (1)