Download Protocol title E.C.CO. Endometrial Cancer – COnservative treatment

E.C.CO.
Protocol title
Study Type
Primary Objective
Secondary Objective
Inclusion criteria
Exclusion criteria
Treatment
Duration of study
Endometrial Cancer – COnservative treatment
A multicentre registry study
Observational, prospective (patient registry)
[The study runs within the framework of Gynecologic Cancer InterGroup (GCIG),
thus, participating centres must belong to one of the qualified national groups]
- Proportion of complete regression
- Duration of response
- Frequency and pattern of relapse
- Frequency of metachronous ovarian cancer
- Tumor-related deaths
- Treatment related morbidity
- Frequency of spontaneous pregnancies
- Frequency of pregnancies after ART
- Pattern of residual disease on definitive surgical specimens
- Age up to 40 years
- Histologically proven EC
- Strong desire to preserve fertility and complete the follow-up program
- Oncology and fertility counseling and informed consent
- History of previous/concomitant cancer (except for adequately treated skin basal
cell or in situ cervical cancer)
- Patient belonging to a family with hereditary non-polyposis colorectal cancer
(Lynch II syndrome)
- Synchronous ovarian cancer at magnetic resonance imaging (MRI) or laparoscopy
- Contraindications for progestin treatment or levonorgestrel-releasing intrauterine
system (LNG-IUS) insertion
- Since this is a registry study, there is not one defined protocol, but treatment,
however, is to be administered according to a IRB-approved protocol (except for
the countries where conservative treatment can be given outside a IRB-approved
study because considered as a standard procedure). Already active protocols in
GCIG member institutions are incorporated in the study package and recommended
- Pretreatment fertility counseling and patient informed consent are considered
mandatory
- Pathological criteria are defined for differential diagnosis of endometrial
hyperplasia and low grade adenocarcinoma
- Definitive surgery should be planned, and pathological data available
A first phase of three years is planned, eventually followed by further three years.
For information, please contact:
Stefano Greggi – Istituto Nazionale Tumori di Napoli
[email protected]