The ENGOT plan for rare gyn cancer S. Pignata ENGOT Chair - - PowerPoint PPT Presentation

The ENGOT plan for rare gyn cancer

• S. Pignata

ENGOT Chair National Cancer Institute of Naples Italy

• Progress in gynaecologic oncology needs clinical

studies, translational research and cooperation…

• In rare tumours questions are complex and definitive

answers need trials within reasonable time.

• Trials are unfeasible by a single National group

Rationale for ENGOT rare cancer plan

ENGOT MAP 2017

GROINS AGO-Germany TRSGO HeCOG ISGO MITO MaNGO GEICO GINECO BGOG EORTC- GCG NCRI SGCTG PGOG

• Decision taken to promote a specific plan for rare

cancers

• Questionnaire to the groups to collect all ongoing

activities

• Identification of a single person per group joining this

working group

October strategic meeting

• 45 different projects were declared (retrospective,

prospective registry, phase 2 trials)

– 23 projects happy for external collaboration – 10 projects overlapping, possibly able to merge – 2 projects combine registry and tumour sample collections

 Meeting in september to present the projects and to be discussed about collaboration or improvement ….

• Meeting in september with the rare tumour

representatives

• Presentation of the trials searching collaboration;

discussion on possible merging of initiatives

• Discussion on type of studies to be performed

Plan

• Retrospective (studies that can involve all ENGOT groups)
• Registry/prospective
• New drugs in specific disease (i.e. Alienor)
• New drugs (umbrella trials in rare gyn disease)
• «Joint-Venture» duplicating clinical trials for future meta

analysis (NRG/D Gershenson Project)

• Tumour banking (trial specific or connected to registries)

Type of trials

• CTO arm acceptable
• letrozole monotherapy

arm acceptable?

• Use of bevacizumab?
• Feasibility of parallel

trials with single data center anticipated Meta analysis

• TR biomarkers

Eligib le Patie nts

Letrozole x 6 cycles Paclitaxel + Carboplatin x 6 cycles

Randomizat ion #1

Observation until disease progression

• r severe toxicity

Letrozole until disease progression

• r severe toxicity

Letrozole until disease progression

• r severe toxicity

Randomizati

• n #2

Randomization #1 will be done in a 5:2 ratio (250 to CT, and 100 to L) Stratified by residual disease (< 1 cm vs > 1 cm) Randomization #2 will be done in a 1:1 ratio Stratified by no persistent vs persistent disease

A randomized, 3-arm phase III trial of paclitaxel/carboplatin versus paclitaxel/carboplatin/maintenance letrozole versus letrozole monotherapy in patients with stage II-IV, primary low-grade serous carcinoma of the ovary or peritoneum

ENGOT network to make it a big GCIG trial

ENGOT Biobanking

J Sehouli; I Braicu

• A plan to improve research for rare gyn cancer in

ENGOT

• Close collaboration and regular update to GCIG
• Thanks to Isabelle and sorry for not being with you
• CIAO!!!

Conclusions

SoA project (Lyon, Automne France 2018)

• Goals

– evidence base for diagnose and management of rare gynecological cancers. – multidisciplinary conference will provide comprehensive state-of-the art summaries from key note speakers, – Audience Gyn, Onco, Onco-gyn, RT, biologists – Up to date scientific reviews on

• biology,
• biomarkers,
• preservation of fertility,
• specificity by subgroups of rare cancers,
• updated GCIG/ESGO guidelines,
• unanswered questions and future clinical trials.

SoA project (Lyon, France Automne 2018) 400 to 500 persons

• Organisation

– Faculties 20 to 30 speakers – 2 days meeting

• General sessions
• Breakout sessions
• Lecture

– Sponsoring

• Industries
• ESGO
• …