e.c.co. endometrial cancer conservative treatment · treatment is not dictatedby a protocol,...

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

[email protected]; [email protected]

PROJECT TYPE / DESIGN & TIME PERSPECTIVEObservational / Patient archive, Prospective (a first phase of three years is planned, eventually followed byfurther 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 (orstatement that such treatment is considered as a standard)

INTERVENTIONS & OUTCOME MEASURESData 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

TREATMENTSINCE THIS IS A ARCHIVE, TREATMENT IS NOT DICTATED BY A PROTOCOL, HOWEVER, TREATMENT HAS TO BE ADMINISTEREDACCORDING TO A IRB-APPROVED LOCAL PROTOCOL (except for the countries where conservative treatment can begiven outside a IRB-approved study because considered as a standard procedure)



Country Sites PI #pts registered

Naples, NCI Greggi S. 33

Rome, Catholic University Scambia G 19

Avellino, Malzoni Center Malzoni M. 10

Wien, University Polterauer S. 7

Bergamo, ‘Papa Giovanni XXIII’ H Malandrino C. 6

Milan, ‘S. Raffaele’ H De Marzi P. 4

Naples, Ist University Zullo F. 3

Bari, ‘Giovanni Paolo II’ H Cormio G. 2

Fudan, University Chen X. -

Leiden, University - -

Parkville, Royal Women's H - -

Rome, NCI Vizza E. -

Varese, F. Del Ponte H Ghezzi F. -

Participation (21.05.2019)

Tot. 84



A CRF has been addedMutational Status



Application of the Proactive Molecular Risk Classifier for Endometrial Cancer (ProMisE)

to patients conservatively treated



MMR, POLE/POLD1 and p53 results across the cohort



Case # MMR IHC abn POLE/POLD1 p53 IHC Second cancer Current status1 - - wt - NED2 - - wt - NED3 MSH6; PMS2 - wt - NED4 PMS2 - abn Intestinal DOD*5 - - wt Ovarian NED6 - - wt - NED7 MSH2; MSH6 EDM wt - NED8 MSH2; MSH6 - wt - NED9 - EDM wt - NED

10 MSH6 EDM wt Breast AWD**11 MSH2; MSH6 - wt - NED12 - - wt - NED13 - - wt Ovarian NED14 MSH2 - wt - AWD‡15 - - wt - NED

Application of the Proactive Molecular Risk Classifier for Endometrial Cancer (ProMisE)

to patients conservatively treated

*Right-sided colon cancer. **Breast cancer. ‡Endometrial intraepithelial neoplasia



CONTACT INFORMATION

STEFANO GREGGI, MD, PhDGynecologic Oncology Surgery,

Istituto Nazionale Tumori “Fondazione G. Pascale”Via M. Semmola, 80131, Naples, Italy

Tel.: +39 0815903320; Fax: +39 0815903851E-mail: [email protected]

Cytoreductive Surgery in Advanced Endometrial Cancer

Multicenter Retrospective Study

Ongoing Trial – status update

Objectives

To explore the feasibility of a biomolecular grouping analysis (ProMisEmolecular classifier)**potential subsequent prospective phase to validate

To document the treatment strategy adopted in oncology referencecenters for patients with primary AEC;

To identify the predictors of survival;

To formulate a hypothesis for selection criteria/predictive factors forsuccessful CRS in AEC;

1

2

3

4

Cytoreductive Surgery in Advanced Endometrial CancerMulticenter Retrospective Study




Eligibility

Patients with primary advanced endometrial cancer

treated during the period 2005 – 2015

Inclusion criteriaFIGO Stage: IIIA bulky*; IIIB; IIIC1 bulky*; IIIC2 bulky*; IVA; IVB intraabdominal

* diagnosed by pre-operative imaging techniques and/or intraoperatively

Exclusion criteria- Age >75 y;

- Performance Status (ECOG) >1;

- Patients treated for strictly palliative purposes;

- Patients with second malignancies who had been treated by laparotomy or

who had a therapy that could interfere with the treatment of AEC



Country Sites Group Recruitment # pts registered

Naples, NCI MITO Active 35

Bari, NCI MITO Active 57

Reggio Emilia, ‘S. Maria Nuova’ H MITO Active 10

Trieste, ‘Burlo Garofolo’ H MITO Active 6

Rome, S. Giovanni Addolorata H MITO Active 5

Naples, Ist University MITO Active 1

Avellino, Malzoni Center MITO Active 0

Varese, F. Del Ponte H MITO Active 0

Bern, University SAKK Active 0

Bergamo, ‘Papa Giovanni XXIII’ H MITO pending -

Milan, ‘S. Raffaele’ H MITO pending -

München, University AGO pending -

Fudan, University SGOG pending -

Sidney, Westmead H ANZGOG pending -

Participating site status 21.05.2019

Tot. 114



http://www.usc-intnapoli.netStudy package available on



CONTACT INFORMATION

STEFANO GREGGI, MD, PhDGynecologic Oncology Surgery,

Istituto Nazionale Tumori “Fondazione G. Pascale”Via M. Semmola, 80131, Naples, Italy

Tel.: +39 0815903320; Fax: +39 0815903851E‐mail: [email protected]



e.c.co. endometrial cancer conservative treatment · treatment is not dictatedby a protocol,...

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