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A phase III Trial of postoperative chemotherapy or no further treatment for patients with
node-negative stage I-II intermediate or high risk endometrial cancer.
ENGOT-EN2-DGCG / EORTC-55102
Supported by
Endometrioid:Stage I - G3; II
Non-endometrioid:Stage I-II
ChemotherapyCarboplatin-Paclitaxel x 6+ Brachytherapy
Observation+ Brachytherapy
Sponsor: DGCGProject Manager: Eva RønnengartStatistitian: DePont Christensen
PI: Mirza
Randomization: 1:1N=678
GROUP NATIONAL COORDINATOR No. SITES/ no of open
SITES
SUBMISSION STATUS SIV No. of patients
included
DGCG
DenmarkMansoor Raza Mirza, Copenhagen
6/ 6 CA Approved
EC ApprovedDone 53
NSGO
Finland
Annika Auranen, Tampere 6/ 5 CA Approved
EC ApprovedDone 5
NSGO
Sweden
Caroline Lundgren, Stockholm 4/ 4 CA Approved
EC PendingDone 26
EORTC Frederic Amant, U.Z.Gasthuisberg 27/ 27CA Approved
EC ApprovedDone 45
BGOG Frederic Kridelka, CHU de Liège 10/ 8CA Approved
EC ApprovedDone 8
MITO Stefano Greggi, Naples 8-10/ 1CA Approved
EC Approved2
MaNGO Annamaria Ferrero, Torino 6/ 1CA Approved
EC partly submitted1
C-GOG Pamela Soliman, MD Anderson 1/ 1CA Approved
EC ApprovedDone 1
GEICOAna Santaballa, Hosiptal
Universitario Le Fe10/ 5
CA Approved
EC partly submitted2
ISGO Tally Levy, Wolfson Medical Centre 7/ 0CA Approved
EC Approved
Planned November
2nd 2016
CEEGOG David Cibula, Prague 5/ 0CA Approved
EC not submitted
NOGGODr Jalid Sehouli, Charité Campus
Virchow-Klinikum Berlin5/ 0
CA Approved
EC partly submitted
Total 97/58 143
ARM ACarboplatin + Paclitaxel
+Nintedanib
Investigator’s
choice (without
niraparib)
ARM BCarboplatin + Paclitaxel
+Placebo
Endometrial Cancer
Stage 3 or
Stage 4 or
First relapse
Treat to PD/toxicity
Randomize
Treat to PD/toxicity
Randomization: 1:1
n=148
Stratifications
• stage of disease (stage 3 vs. stage 4 vs. recurrent disease)
• Prior adjuvant chemotherapy (yes/no)
• Disease status (no macroscopic dis vs. macroscopic dis)
A randomized double-blind placebo-controlled phase II trial of first-line combination
chemotherapy with Nintadenib for patients with advanced or recurrent endometrial cancer
ENGOT-EN1 / FANDANGO
Sponsor: NSGOProject Manager: Kicki JederudStatistitian: DePont Christensen
PI: Mirza
GROUP NATIONAL COORDINATOR No. SITES SUBMISSION STATUS SIV performed/planned
NSGODenmark
Mansoor Raza Mirza, Copenhagen 4 CA Approved
EC Approved3 SIVs performed
NSGOFinland
Johanna Mäenpää, Tampere 3 CA Pending
EC ApprovedPlanned Oct/Nov 2016
NSGONorway
Gunnar Kristensen, Oslo1 CA Approved
EC PendingPlanned Oct 2016
NSGOSweden
Per Rosenberg, Linköping 4
CA Approved
EC ApprovedPlanned Oct/Nov 2016
NOGGODr Jalid Sehouli, Charité Campus Virchow-
Klinikum Berlin12
CA Approved
EC ApprovedPlanned Nov 2016
BGOGDr Sevilay Altintas UZ Antwerpen
6CA Submitted 30th Sep 2016
EC Submitted 4th Oct 2016
GINECODr Dominique Bertron-Rigaud
ICO Centre René Gauducheau Saint-Herblain11
CA Submitted 28th Sep 2016
EC Submitted 29th 2016
Total 41
Endometrial Cancer
Primary stage 4 or relapsed disease
ER positive endometrioid
adenocarcinoma
Randomize
Randomization: 1:1N=78
ARM ALetrozole, 2.5mg d 1-28 every 28 daysPlacebo 125mg d 1-21 every 28 days
Until progression
ARM BLetrozole, 2.5mg d 1-28 every 28 days
Palbociclib 125mg d 1-21 every 28 days Until progression
Stratification:• Number of prior lines of therapy (primary advanced disease vs. 1st
relapse vs. ≥2 relapses)• Measurable vs. evaluable disease• Prior use of MPA/Megace (prior MPA/Megace use capped to a
maximum of 50%)
A randomized, double-blind, placebo-controlled, phase II trial of Palbociclib in combination
with Letrozole versus Placebo in combination with Letrozole for patients with Estrogen
receptor Positive advanced or recurrent Endometrial cancer.
ENGOT-EN3-NSGO/PALEO
Sponsor: NSGO
Sponsor: NSGOProject Manager: Joan LøhndorfStatistitian: DePont Christensen
PI: Mirza
GROUP NATIONAL COORDINATOR No. SITES SUBMISSION STATUS
NSGO
Denmark
Mansoor Raza Mirza, Copenhagen 3 CA Approved
EC Approved
NSGO
Finland
Annika Auraen, Tampere 3 CA planned submission mid October
EC planned submission mid October
NSGO
NorwayLine Bjørge, Bergen
2 CA planned submission start November
EC planned submission start November
NOGGO
GermanyJalid Sehouli, Berlin 5
CA planned submission during November
EC planned submission during November
MITO
ItalyGiovanni Scambia, Rome 6
CA planned submission during November
EC planned submission during November
GEICO
SpainDr. Cesar Mendiola, HU 12 de Octubre 5
CA planned submission during November
EC planned submission during November
Total 24