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 Randomization: 1:1 N=678
Chemotherapy Endometrioid: Stage I - G3; II Non-endometrioid: Stage I-II
CarboplatinPaclitaxel x 6 + Brachytherapy
Observation + Brachytherapy
Sponsor: DGCG Project Manager: Eva Rønnengart Statistitian: DePont Christensen PI: Mirza
Supported by
GROUP
DGCG Denmark
NATIONAL COORDINATOR
Mansoor Raza Mirza, Copenhagen
No. SITES/ no of open SITES
SUBMISSION STATUS SIV
No. of patients included
6/ 6
CA Approved EC Approved
Done
53
NSGO Finland
Annika Auranen, Tampere
6/ 5
CA Approved EC Approved
Done
5
NSGO Sweden
Caroline Lundgren, Stockholm
4/ 4
CA Approved EC Pending
Done
26
EORTC
Frederic Amant, U.Z.Gasthuisberg
27/ 27
CA Approved EC Approved
Done
45
BGOG
Frederic Kridelka, CHU de Liège
10/ 8
CA Approved EC Approved
Done
8
MITO
Stefano Greggi, Naples
8-10/ 1
CA Approved EC Approved
2
MaNGO
Annamaria Ferrero, Torino
6/ 1
CA Approved EC partly submitted
1
C-GOG
Pamela Soliman, MD Anderson
1/ 1
CA Approved EC Approved
GEICO
Ana Santaballa, Hosiptal Universitario Le Fe
10/ 5
CA Approved EC partly submitted
ISGO
Tally Levy, Wolfson Medical Centre
7/ 0
CA Approved EC Approved
CEEGOG
David Cibula, Prague
5/ 0
CA Approved EC not submitted
NOGGO
Dr Jalid Sehouli, Charité Campus Virchow-Klinikum Berlin
5/ 0
CA Approved EC partly submitted
Total
97/58
Done
1 2
Planned November 2nd 2016
143
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
Randomization: 1:1 n=148
ARM A Endometrial Cancer Stage 3 or Stage 4 or First relapse
Carboplatin + Paclitaxel + Nintedanib
Investigator’s choice (without niraparib)
Randomize
ARM B Carboplatin + Paclitaxel + Placebo
Sponsor: NSGO Project Manager: Kicki Jederud Statistitian: DePont Christensen PI: Mirza
[email protected]
Treat to PD/toxicity
Stratifications • stage of disease • Prior adjuvant chemotherapy • Disease status
Treat to PD/toxicity
(stage 3 vs. stage 4 vs. recurrent disease) (yes/no) (no macroscopic dis vs. macroscopic dis)
GROUP
NATIONAL COORDINATOR
No. SITES
SUBMISSION STATUS
SIV performed/planned
NSGO Denmark
Mansoor Raza Mirza, Copenhagen
4
CA Approved EC Approved
3 SIVs performed
NSGO Finland
Johanna Mäenpää, Tampere
3
CA Pending EC Approved
Planned Oct/Nov 2016
1
CA Approved EC Pending
Planned Oct 2016
4
CA Approved EC Approved
Planned Oct/Nov 2016
12
CA Approved EC Approved
Planned Nov 2016
6
CA Submitted 30th Sep 2016 EC Submitted 4th Oct 2016
11
CA Submitted 28th Sep 2016 EC Submitted 29th 2016
NSGO Norway
Gunnar Kristensen, Oslo
NSGO Sweden
Per Rosenberg, Linköping
NOGGO
Dr Jalid Sehouli, Charité Campus VirchowKlinikum Berlin
BGOG
Dr Sevilay Altintas UZ Antwerpen
GINECO
Dr Dominique Bertron-Rigaud ICO Centre René Gauducheau Saint-Herblain
Total
[email protected]
41
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. Randomization: 1:1 N=78
ENGOT-EN3-NSGO/PALEO Sponsor: NSGO
ARM A Letrozole, 2.5mg d 1-28 every 28 days Placebo 125mg d 1-21 every 28 days Until progression
Endometrial Cancer
Primary stage 4 or relapsed disease
ER positive endometrioid adenocarcinoma
Sponsor: NSGO Project Manager: Joan Løhndorf Statistitian: DePont Christensen PI: Mirza
Randomize
ARM B Letrozole, 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%)
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
2
CA planned submission start November EC planned submission start November
NSGO Norway
Line Bjørge, Bergen
NOGGO Germany
Jalid Sehouli, Berlin
5
CA planned submission during November EC planned submission during November
MITO Italy
Giovanni Scambia, Rome
6
CA planned submission during November EC planned submission during November
GEICO Spain
Dr. Cesar Mendiola, HU 12 de Octubre
5
CA planned submission during November EC planned submission during November
Total
24
