E.C.Co. E ndometrial C ancer Co nservative treatment A multicentre - - PowerPoint PPT Presentation

INTERNATIONAL GYNECOLOGIC CANCER SOCIETY 16TH

BIENNIAL MEETING OF THE

E.C.Co. Endometrial Cancer Conservative treatment A multicentre archive

Data collection is made by appropriate eCRFs via the Clinical Trials Unit of National Cancer Institute of Naples (Study Data Center) website

s.greggi@istitutotumori.na.it; ginecologia@istitutotumori.na.it

PROJECT TYPE / DESIGN & TIME PERSPECTIVE Observational / Patient archive, Prospective (a first phase of three years is planned, eventually followed by further three years) INCLUSION CRITERIA

• Conservatively treated endometrial cancer
• 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) INTERVENTIONS & OUTCOME MEASURES Data collection - 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 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)

E.C.Co. Endometrial Cancer Conservative treatment A multicentre archive

Participation (15/10/2016)

E.C.Co. Endometrial Cancer Conservative treatment A multicentre archive

Center Code PI Registration date N° of patients registered

National Cancer Institute of Naples,

• Naples. Italy

640 Stefano Greggi March 2014 28 Catholic University

• f

the Sacred Heart, Rome. Italy 145 Giovanni Scambia September 2015 10 Papa Giovanni XXIII Hospital,

• Bergamo. Italy

254 Chiara Malandrino December 2015 6 San Raffaele Hospital, Milan. Italy 321 Patrizia De Marzi October 2015

• National Cancer Institute of Rome,
• Rome. Italy

741

• July 2016
• University of Bari, Bari. Italy

111 Gennaro Cormio October 2015

• The

Royal Women’s Hospital,

• Parkville. Australia

668

• August 2015
• The Obstetrics & Gynecology Hospital
• f Fudan University, Shanghai. China

676

• September 2015
• Leiden

Medical University, Leiden. Netherlands 704

• September 2015
• Tot N 44