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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04290299




Registration number
NCT04290299
Ethics application status
Date submitted
27/02/2020
Date registered
28/02/2020
Date last updated
13/10/2021

Titles & IDs
Public title
Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive
Scientific title
Endometrial Cancer Conservative Treatment (E.C.Co). A Multicentre Archive
Secondary ID [1] 0 0
13/15 oss
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Data collection

Other interventions: Data collection
Cancer (response, relapse) and fertility (pregnancy, delivery) outcomes
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of complete regression
Timepoint [1] 0 0
10 years
Primary outcome [2] 0 0
Duration of response
Timepoint [2] 0 0
10 years
Primary outcome [3] 0 0
Frequency of relapse
Timepoint [3] 0 0
10 years
Primary outcome [4] 0 0
Pattern of relapse
Timepoint [4] 0 0
10 years
Primary outcome [5] 0 0
Frequency of metachronous ovarian cancer
Timepoint [5] 0 0
10 years
Primary outcome [6] 0 0
Tumor-related deaths
Timepoint [6] 0 0
10 years
Secondary outcome [1] 0 0
Treatment related morbidity
Timepoint [1] 0 0
10 years
Secondary outcome [2] 0 0
Frequency of spontaneous pregnancies
Timepoint [2] 0 0
10 years
Secondary outcome [3] 0 0
Frequency of pregnancies after ART
Timepoint [3] 0 0
10 years
Secondary outcome [4] 0 0
Frequency of residual disease on definitive surgical specimens
Timepoint [4] 0 0
10 years

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
-

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/04/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
ANZGOG - Australia and New Zealand Gynecological Oncology Group - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels
Country [4] 0 0
Canada
State/province [4] 0 0
Ottawa
Country [5] 0 0
Canada
State/province [5] 0 0
Toronto
Country [6] 0 0
China
State/province [6] 0 0
Shangai
Country [7] 0 0
Denmark
State/province [7] 0 0
Copenhagen
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Ireland
State/province [10] 0 0
Dublin
Country [11] 0 0
Italy
State/province [11] 0 0
Naples
Country [12] 0 0
Japan
State/province [12] 0 0
Kato
Country [13] 0 0
Japan
State/province [13] 0 0
Tokyo
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seul
Country [15] 0 0
Netherlands
State/province [15] 0 0
Amsterdam
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Edinburgh

Funding & Sponsors
Primary sponsor type
Other
Name
National Cancer Institute, Naples
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04290299
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stefano Greggi, MD
Address 0 0
National Cancer Institute of Naples
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stefano Greggi, MD
Address 0 0
Country 0 0
Phone 0 0
+39.081.5903417
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04290299