Closed Trials & Publications

ENGOT-ov49/MaNGO/NEWTON

Leading group: MaNGO

Clinical Trial Study: A multicenter, open-label phase II trial of customized dosing (Rapid Adjustment of Dose to reduce Adverse Reactions “RADAR” dosing) of niraparib as maintenance therapy in platinum sensitive ovarian, fallopian tube or primary peritoneal recurrent cancer patients. 

Final number of patients: 58

Participating groups:

NOGGO

Closure: 2022

Publications: TBA

 

ENGOT-ov48/BGOG/EUDARIO

Leading group: BGOG

Clinical Trial Study: European trial on enhanced DNA repair Inhibion in ovarian cancer (EUDARIO)

Final number of patients: 120

Participating groups:

A-AGO, GINECO, MITO, NOGGO

Closure: 2021

Publications: TBA

 

ENGOT-ov46/AGO/DUO-O

Leading group: 

Clinical Trial Study: A phase III randomised, double-blind, placebo-controlled, multicentre study of Durvalumab (MEDI4736) in combination with chemotherapy and Bevacizumab, followed by maintenance Durvalumab, Bevacizumab and Olaparib in newly diagnosed advanced ovarian cancer patients (DUO-O)

Final number of patients: 1284

Participating groups:

A-AGO, BGOG, GEICO, GINECO, MaNGO, MITO, NSGO-CTU, PGOG, TRSGO

Closure: 2021

Publications: TBA

 

ENGOT-ov45/NCRI/ATHENA

Leading group: NCRI

Clinical Trial Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment following Response to Front-Line Platinum-Based Chemotherapy

Final number of patients: 1082

Participating groups:

AGO-De, BGOG, CEEGOG, CTI, GEICO, HeCOG, ISGO, MITO, NSGO-CTU, PGOG, TRSGO

Closure: 2020

Publications: Journal of Clinical Oncology vol.40, Issue 34, June 6 2022

 

ENGOT-ov44/GINECO/FIRST

Leading group: GINECO

Clinical Trial Study: A randomized phase III comparing platinum and TSR-042 (PD-L1 inhibitor) followed by Niraparib and TSR-042 maintenance therapy versus  adaptive standard platinum-based treatment in patients with stage III or IV cancer of the ovary, fallopian tube or peritoneum

Final number of patients: 1050

Participating groups:

AGO, BGOG, CEEGOG, DGOG, GEICO, HeCOG, ISGO, MITO, NCRI, NSGO

Closure: 2021

Publications: TBA - First results planned by the end of 2023

 

ENGOT-ov43/BGOG/MK7339-001

Leading group: BGOG

Clinical Trial Study: Randomized phase III first line study in ovarian cancer comparing paclitaxel carboplatinum, with paclitaxel/carboplatin and pembrolizumab and olaparib

Final number of patients: 1367

Participating groups:

CEEGOG, GEICO, GINECO, ISGO, MANGO, MITO, NOGGO, PGOG, TRSGO

Closure: 2021

Publications: TBA

 

ENGOT-ov39/MITO/IMaGYN 050

Leading group: MITO

Clinical Trial Study: A phase III, multicenter, randomized, study of atezolizumab versus placebo administered in combination with paclitaxel, carboplatin, and bevacizumab to patients with paclitaxel, carboplatin, and bevacizumab to patients with newly-diagnosed Stage III or Stage IV ovarian, fallopian tube, or primary peritoneal cancer

Final number of patients: 1278

Participating groups:

A-AGO, AGO, BGOG, MaNGO, NSGO, CEEGOG, GEICO, GINECO, HeCOG, PGOG, TRSGO, ISGO

Closure: 2020

Publications: DOI: 10.1200/JCO.21.00306

 

ENGOT-ov38/GINECO/OReO

Leading group: GINECO

Clinical Trial Study: Double blind phase IIIb study: Olaparib Retreatment in late recurrent Ovarian cancer

Final number of patients: 160

Participating groups:

AGO, BGOG, GEICO, ISGO, MITO, NSGO, SGCTG, MaNGO, NCRI, PGOG

Closure: 2020

Publications: DOI:https://doi.org/10.1016/j.annonc.2021.08.2110

 

ENGOT-ov36/SGCTG – NSGO

Leading group: SGCTG

Clinical Trial Study: A phase II trial of a triple angiokinase inhibitor (BIBF1120) in the treatment of patients with recurrent clear cell ovarian cancer

Final number of patients: 102

Participating groups:

EORTC, GINECO, NCRI, NSGO

Closure: 2020

Publications: Primary results were presented at ESGO 2020

 

ENGOT-ov32/MITO

Leading group: MITO

Clinical Trial Study: Randomized phase III trial on Trabectedin (ET 743) vs clinician’s choice chemotherapy in recurrent ovarian, primary peritoneal or fallopian tube cancers of BRCA mutated or BRCAness phenotype patients

Final number of patients: 244

Participating groups:

MaNGO, GEICO

Closure: 2019

Publications: TBA

 

ENGOT-ov31/AGO Ovar OP.3/Lion

Leading group: AGO

Clinical Trial Study: Lion: Lymphadenectomy In Ovarian Neoplasms

Final number of patients: 650

Participating groups:

A-AGO, BGOG, MaNGO, MITO, (KGOG)

Closure: 2017

Publications: 

A Randomized Trial of Lymphadenectomy in Patients with Advanced Ovarian Neoplasms

Philipp Harter, M.D., Ph.D., Jalid Sehouli, M.D., Ph.D., Domenica Lorusso, M.D., Alexander Reuss, M.Sc., Ignace Vergote, M.D., Ph.D., Christian Marth, M.D., Ph.D., Jae-Weon Kim, M.D., Ph.D., Francesco Raspagliesi, M.D., Ph.D., Björn Lampe, M.D., Ph.D., Giovanni Aletti, M.D., Werner Meier, M.D., Ph.D., David Cibula, M.D., Ph.D., Alexander Mustea, M.D., Ph.D., Sven Mahner, M.D., Ph.D., Ingo B. Runnebaum, M.D., Ph.D., Barbara Schmalfeldt, M.D., Ph.D., Alexander Burges, M.D., Ph.D., Rainer Kimmig, M.D., Ph.D., Giovanni Scambia, M.D., Ph.D., Stefano Greggi, M.D., Ph.D., Felix Hilpert, M.D., Ph.D., Annette Hasenburg, M.D., Ph.D., Peter Hillemanns, M.D., Ph.D., Giorgio Giorda, M.D., Ingo von Leffern, M.D., Carmen Schade-Brittinger, B.Sc., Uwe Wagner, M.D., Ph.D., and Andreas du Bois, M.D., Ph.D.

N Engl J Med 2019; 380:822-832

DOI: 10.1056/NEJMoa1808424

 

ENGOT-ov30/NSGO-CTU/UMB1

Leading group: NSGO-CTU

Clinical Trial Study: A phase II umbrella trial in patients with relapsed ovarian cancer

Final number of patients: 25

Participating groups: EORTC, SGCTG, BGOG, NOGGO, (ANZGOG, KGOG,COGI, GOTIC, PMHC)

Closure: 2020

Publications: LBA at ESGO 2021

 

ENGOT-ov29/GINECO/ATALANTE

Leading group: GINECO

Clinical Trial Study: Randomized trial comparing atezolizumab versus placebo in patients with 1st or 2nd platinum-sensitive relapse of OC treated with carboplatin combination + bevacizumab

Final number of: 613

Participating groups:

A-AGO, AGO, BGOG, CEECOG, GEICO, ISGO

Closure: 2020

Publications: First results planned in 2022

 

ENGOT-ov27/BGOG-ov18/MORAB003-011

Leading group: BGOG

Clinical Trial Study: A Randomized, double-blind, placebo-controlled, phase 2 study to assess the efficacy and safety of Farletuzumab (MORAb 003) in combination with Carboplatin plus Paclitaxel or Carboplatin plus Pegylated Liposomal Doxorubicin (PLD) in subjects with low CA125 platinum-sensitive ovarian cancer

Final number of patients: 186

Participating groups:

GEICO, MITO, NOGGO

Closure: 2018

Publications: TBA

 

ENGOT-ov26/GEICO/1509 - PRIMA study

Leading group: GEICO

Clinical Trial Study: A phase 3, randomized, double-blind, placebo-controlled, multicenter study of Niraparib maintenance treatment in patients with advanced ovarian cancer following response on front-line platinum-based chemotherapy

Final number of patients: 468

Participating groups:

AGO, BGOG, Cancer Trials Ireland, GINECO, ISGO, MITO, NSGO

Closure: 2019

Publications: TBA

 

ENGOT-ov25/GINECO/PAOLA

Leading group: GINECO

Clinical Trial Study: Phase III trial of olaparib versus placebo combined with bevacizumab as maintenance treatment in patients with advanced ovarian cancer following first-line platinum-based chemotherapy plus bevacizumab

Final number of patients: 806

Participating groups:

A-AGO, AGO, BGOG, GEICO MaNGO, MITO, NSGO, (GOTIC)

Closure: 2017

Publications: 

• Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer

Ray-Coquard I, Pautier P, Pignata S, Pérol D, González-Martín A, Berger R, Fujiwara K, Vergote I, Colombo N, Mäenpää J, Selle F, Sehouli J, Lorusso D, Guerra Alía EM, Reinthaller A, Nagao S, Lefeuvre-Plesse C, Canzler U, Scambia G, Lortholary A, Marmé F, Combe P, de Gregorio N, Rodrigues M, Buderath P, Dubot C, Burges A, You B, Pujade-Lauraine E, Harter P; PAOLA-1 Investigators.

N Engl J Med. 2019 Dec 19;381(25):2416-2428

 

ENGOT-ov24/NSGO/AVANOVA

Leading group: NSGO

Clinical Trial Study: Niraparib and/or Niraparib-bevacizumab combination against bevacizumab alone in women with platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer

Final number of patients: 98

Participating groups:

GEICO, ISGO, MITO

Closure: 2019

Publications: 

• Niraparib plus bevacizumab versus niraparib alone for platinum-sensitive recurrent ovarian cancer (NSGO-AVANOVA2/ENGOT-ov24): a randomised, phase 2, superiority trial

Mansoor Raza Mirza, Elisabeth Åvall Lundqvist, Michael J Birrer, Rene dePont Christensen, Gitte-Bettina Nyvang, Susanne Malander,
Maarit Anttila, Theresa L Werner, Bente Lund, Gabriel Lindahl, Sakari Hietanen, Ulla Peen, Maria Dimoula, Henrik Roed, Anja Ør Knudsen,
Synnöve Staff, Anders Krog Vistisen, Line Bjørge, Johanna U Mäenpää, for the AVANOVA investigators*

Lancet Oncol 2019; 20: 1409-1419

 

• A phase I study of the PARP inhibitor niraparib in combination with bevacizumab in platinum-sensitive epithelial ovarian cancer: NSGO AVANOVA1/ENGOT-OV24

Mirza MR, Bergmann TK, Mau-Sørensen M, Christensen RD, Åvall-Lundqvist E, Birrer MJ, Jørgensen M, Roed H, Malander S, Nielsen F, Lassen U, Brøsen K, Bjørge L, Mäenpää J

Cancer Chemother Pharmacol. 2019 Oct; 84(4):791-798. Doi: 10.1007/s00280-019-03917-z. Epub 2019 Aug 2

 

ENGOT-ov23/GINECO/EWOC-1

Leading group: GINECO

Clinical Trial Study: Multicenter, randomized trial of carboplatin +/-paclitaxel in vulnerable elderly patients with stage IIB- IV advanced ovarian cancer

Final number of patients: 120

Participating groups: MITO, NSGO

Closure: 2019

Publications:

• ASCO 2019
• submission in Lancet Oncology

 

ENGOT-ov22/NOGGO/ Expression IV

Leading group: NOGGO

Clinical Trial Study: Expression IV - What do primary and recurrent ovarian cancer (OC) patients expect from maintenance therapy?

Final number of patients: 2101

Participating groups: 

A-AGO, AGO, BGOG, GINECO, MaNGO, MITO, NSGO

Closure: 2016

Publications: TBA

 

ENGOT-ov21/GINECO/Solo2

Leading group: GINECO

Clinical Trial Study: Phase III Study in BRCAm platinum sensitive relapsed ovarian cancer patients

Final number of patients: 295

Participating groups: 

AGO, BGOG, DGOG, GEICO, ISGO, MaNGO, MITO, NCRI

Closure: 2015

Publications:

• Lancet Oncology, July 2017
• ASCO 2020 (submission in New England Journal of Medicine on-going)

 

ENGOT-ov20/AGO-OVAR OP.4/Desktop 3

Leading group: AGO

Clinical Trial Study: Randomised trial investigating secondary debulking versus no-secondary debulking in platin sensitive disease

Final number of patients: 244? 

Participating groups:

A-AGO, BGOG, GEICO, GINECO, MaNGO, MITO, NSGO, (CRCTU UK, KGOG, SGOG)

Closure: 2020

Publications: 

ASCO 2020

 

ENGOT-ov19/NOGGO/Hector

Leading group: NOGGO

Clinical Trial Study: Topotecan plus carboplatin versus standard therapy with paclitaxel plus carboplatin (PC) or gemcitabine plus carboplatin (GC) or pegylated liposomal doxorubicin plus carboplatin (PLDC): a randomized phase III trial (HECTOR)

Final number of patients: 550

Participating groups:

A-AGO, AGO, GEICO, (GCIG)

Closure: TBA

Publications: 

• Topotecan plus carboplatin versus standard therapy with paclitaxel plus carboplatin (PC) or gemcitabine plus carboplatin (GC) or pegylated liposomal doxorubicin plus carboplatin (PLDC): a randomized phase III trial of the NOGGO-AGO-Study Group-AGO Austria and GEICO-ENGOT-GCIG intergroup study (HECTOR).
  Sehouli J1, Chekerov R2, Reinthaller A3, Richter R2, Gonzalez-Martin A4, Harter P5, Woopen H2, Petru E6, Hanker LC7, Keil E8, Wimberger P9, Klare P10, Kurzeder C5, Hilpert F11, Belau AK12, Zeimet A13, Bover-Barcelo I14, Canzler U9, Mahner S15, Meier W16.

       Ann Oncol. 2016 Dec;27(12):2236-2241. doi: 10.1093/annonc/mdw418. Epub 2016 Oct 26.

 

ENGOT-ov18/AGO-OVAR 2.21

Leading group: AGO

Clinical Trial Study: A prospective randomized phase III trial of carboplatin/gemcitabine/bevacizumab vs. carboplatin/pegylated liposomal doxorubicin/bevacizumab in patients with platinum-sensitive recurrent ovarian cancer

Final number of patients: 682

Participating groups:

A-AGO, GINECO, SGCTG, (ANZGOG)

Closure: 2018

Publications:

• Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial

Prof Jacobus Pfisterer, Catherine M Shannon, Klaus Baumann, Joern Rau, Philipp Harter, Prof Florence Joly, Prof Jalid Sehouli, Ulrich Canzler, Prof Barbara Schmalfeldt, Andrew P Dean , Alexander Hein, Prof Alain G Zeimet, Lars C Hanker, Prof Thierry Petit, Prof Frederik Marmé, Ahmed El-Balat, Rosalind Glasspool, Nikolaus de Gregorio, … Alain Zannetti

Lancet Oncol 2020; 21: 699–709, Published Online, April 16, 2020, https://doi.org/10.1016/, S1470-2045(20)30142-X

 

ENGOT-ov17/MITO 16-MaNGO ov2b

Leading group: MITO

Clinical Trial Study: Phase III trial with second line chemotherapy +/- Bevacizumab in patients with platinum sensitive ovarian cancer recurrence after Bevacizumab and chemotherapy in the first line

Final number of patients: 406

Participating groups:

MaNGO, BGOG, GINECO, HeCOG, SAKK

Closure: 2016

Publications: TBA

 

ENGOT-ov16/NSGO/NOVA

Leading group: NSGO

Clinical Trial Study: Phase 3 randomized double-blind trial of maintenance with Niraparib versus placebo in patients with platinum sensitive ovarian cancer

Final number of patients: 553

Participating groups:

A-AGO, AGO, BGOG, CEEGOG, GEICO, GINECO, ISGO, MaNGO, MITO, NCRI, NOGGO

Closure: TBA

Publications:

• Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer.

Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, Fabbro M, Ledermann JA, Lorusso D, Vergote I, Ben-Baruch NE, Marth C, Mądry R, Christensen RD, Berek JS, Dørum A, Tinker AV, du Bois A, González-Martín A, Follana P, Benigno B, Rosenberg P, Gilbert L, Rimel BJ, Buscema J, Balser JP, Agarwal S, Matulonis UA; ENGOT-OV16/NOVA Investigators.

N Engl J Med. 2016 Dec 1;375(22):2154-2164.

• Efficacy and safety of niraparib as maintenance treatment in older patients (> 70 years) with recurrent ovarian cancer: Results from the ENGOT-OV16/NOVA Trial

Michel Fabbro, Kathleen N. Moore, Anne Dørum, Anna V. Tinkerg, Sven Mahnerh, Isabel Bover, Susana Banerjee, Germana Tognono, Frederic Goffin, Ronnie Shapira-Frommer, Robert M. Wenhamt, Kristina Hellman, Diane Provencher, Philipp Harter, Isabel Palacio Vázquez, Philippe Follana, Mario J. Pineda, Mansoor R. Mirza, Sebastien J. Hazard, Ursula A. Matulonis

Gynecol Oncol. 2019 Jan 9

• Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial

Josep M. del Campo, Ursula A. Matulonis, Susanne Malander, Diane Provencher, Sven Mahner, Philippe Follana, Justin Waters, Jonathan S. Berek, Kathrine Woie, Amit M. Oza, Ulrich Canzler, Marta Gil-Martin, Anne Lesoin, Bradley J. Monk, Bente Lund, Lucy Gilbert, Robert M. Wenham, Benedict Benigno, Sujata Arora, Sebastien J. Hazard and Mansoor R. Mirza

J Clin Oncol 2019, Jun 7

• Niraparib Maintenance Treatment Improves Time Without Symptoms or Toxicity (TWiST) Versus Routine Surveillance in Recurrent Ovarian Cancer: A TWiST Analysis of the ENGOT-OV16/NOVA Trial

Ursula A. Matulonis, Lydia Walder, Trine J. Nøttrup, Paul Bessette, Sven Mahner, Marta Gil-Martin, Elsa Kalbacher, Jonathan A. Ledermann, Robert M. Wenham, Kathrine Woie, Susie Lau, Frederik Marme, Antonio Casado Herraez, Anne-Claire Hardy-Bessard, Susana Banerjee, Gabriel Lindahl, Benedict Benigno, Joseph Buscema, Karin Travers, Holly Guy and Mansoor R. Mirza

J Clin Oncol 2019, Sep 16

 

ENGOT-ov15/AGO-OVAR 17

Leading group: AGO

Clinical Trial Study: A prospective randomised phase III trial to evaluate optimal treatment duration of first-line bevacizumab in combination with carboplatin and paclitaxel in patients with primary epithelial ovarian, fallopian tube or peritoneal cancer. The BOOST (Bevacizumab Ovarian Optiam Standard Treatment) trial 

Final number of patients: 927

Participating Groups:

GINECO, NSGO

Closure: 2021

Publications: TBA

 

ENGOT-ov14/AGO-OVAR 2.20/Penelope

Leading group: AGO

Clinical Trial Study: A randomised phase II study comparing Caelyx or Topotecan or Gemcitabin with or without Pertuzumab in patients low HER3 mRNA platin-resistant ovarian cancer

Final number of patients: 156

Participating groups:

A-AGO, BGOG, DGOG, GEICO, GINECO, MaNGO, MITO, NSGO, TRSGO

Closure: 2016

Publications:

• Publication Part 1:
  Pertuzumab Plus Chemotherapy for Platinum-Resistant Ovarian Cancer: Safety Run-in Results of the PENELOPE Trial
  González-Martín A, Pautier P, Mahner S, Rau J, Colombo N, Ottevanger P, del Campo JM, Selle F, du Bois A, Gadducci A, Garcia Y, Berton-Rigaud D, Marmé F, Ortega E, Martin N, Bastiere-Truchot L, Kiermaier A, Kurzeder C.
  Int J Gynecol Cancer. 2016 Jun;26(5):898-905. doi: 10.1097/IGC.0000000000000695.
  Published online first
• Publication Part 2:
  Double-Blind, Placebo-Controlled, Randomized Phase III Trial Evaluating Pertuzumab Combined With Chemotherapy for Low Tumor Human Epidermal Growth Factor Receptor 3 mRNA–Expressing Platinum-Resistant Ovarian Cancer (PENELOPE)
  Kurzeder C, Bover I, Marmé F, Rau J, Pautier P, Colombo N, Lorusso D, Bjurberg M, Marth C. Barretina-Ginesta P, Vergote I, Floquet A, del Campo JM, Mahner S. Bastiere-Truchot L, Martin N, Oestergaard MZ, Kiermaier A, Schade-Brittinger C, Polleis S, du Bois A and Gonzalez-Martin A
  J Clin Oncol. 2016 Jul 20;34(21):2516-25. doi: 10.1200/JCO.2015.66.0787. Epub 2016 Jun 6

 

ENGOT-ov 13/NCRI/ICON8

Leading group: NCRI

Clinical Trial Study: An international phase III randomised trial of dose fractionated chemotherapy compared to standard three weekly chemotherapy, following immediate primary surgery or as part of delayed primary surgery, for women with newly diagnosed epithelial ovarian, fallopian tube or primary peritoneal cancer

Final number of patients: 1566

Participating groups:

Cancer Trials Ireland, (ANZGOG, GICOM, KGOG)

Closure: 2019 

Publications: TBA 

 

ENGOT-ov 13/NCRI/ICON8B

Leading group: NCRI

Clinical Trial Study: A phase III randomised trial investigating the combination of dose-fractionated chemotherapy and bevacizumab compared to standard three weekly chemotherapy and bevacizumab for the first-line treatment of women with newly diagnosed high-risk stage III-IV epithelial ovarian, fallopian tube or primary peritoneal cancer

Final number of patients: 489

Participating groups:

Cancer Trials Ireland, (CTU EOC)

Closure: 2019

Publications: TBA

 

ENGOT-ov12/MITO-12

Leading group: MITO

Clinical Trial Study: Pathway to diagnosis of ovarian cancer: an observational retrospective multicentre trial

Final number of patients: 700

Participating groups:

BGOG, MaNGO, NOGGO

Closure: 2017

Publications: TBA

 

ENGOT-ov11/BGOG/MILO

Leading group: BGOG

Clinical Trial Study: A multinational, randomised, open-label, Phase 3 study of MEK162 vs. physiian's choice chemotherapy in patients with recurrent or persistent low-grade serous carcinomas of the ovary, fallopian tube or primary peritoneum

Final number of patients: 341

Participating groups:

A-AGO, AGO, Cancer Trials Ireland, CEEGOG, DGOG, GEICO, GINECO, MaNGO, MITO, NSGO

Closure: 2016

Publications: TBA

 

ENGOT-ov10/MITO-7

Leading group: MITO

Clinical Trial Study: First line weekly carboplatin and paclitaxel vs every 3 weeks carboplatin/paclitaxel in patients with ovarian cancer: Phase III multicenter trial. (S. Pignata).

Final number of patients: 822

Participating groups:

GINECO, MaNGO

Closure: TBA

Publications:

• Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomised, multicentre, open-label, phase 3 trial.

  Pignata S, Scambia G, Katsaros D, Gallo C, Pujade-Lauraine E, De Placido S, Bologna A, Weber B, Raspagliesi F, Panici PB, Cormio G, Sorio R, Cavazzini MG, Ferrandina G, Breda E, Murgia V, Sacco C, Cinieri S, Salutari V, Ricci C, Pisano C, Greggi S, Lauria R, Lorusso D, Marchetti C, Selvaggi L, Signoriello S, Piccirillo MC, Di Maio M, Perrone F; Multicentre Italian Trials in Ovarian cancer (MITO-7); Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens et du sein (GINECO); Mario Negri Gynecologic Oncology (MaNGO); European Network of Gynaecological Oncological Trial Groups (ENGOT-OV-10); Gynecologic Cancer InterGroup (GCIG) Investigators.

  Lancet Oncol. 2014 Apr;15(4):396-405
  

 

ENGOT-ov9/NOGGO

Leading group: NOGGO

Clinical Trial Study: A randomized, double-blind, placebo controlled, multicenter Phase II study to assess the efficacy and safety of Sorafenib added to standard treatment with Topotecan in patients with platinum-resistant recurrent ovarian carcinoma

Final number of patients: 174

Participating group: AGO

Closure: 2013

Publications: TBA

 

ENGOT-ov7/GINECO/Alienor

Leading group: GINECO

Clinical Trial Study: Randomized open label Phase II trial of Bevacizumab plus weekly Paclitaxel followed by Bevacizumab monotherapy maintenance versus weekly paclitaxel followed by observation in patients with relapsed sex-cord-stromal tumors

Final number of patients: 60

Participating groups:

AGO, BGOG, MITO, (GOTIC)

Closure: 2018

Publications: 

• ESMO 2018
• Accepted in JAMA Oncology

 

ENGOT-ov6/A-AGO/Trinova 2

Leading group: A-AGO

Clinical Trial Study: A phase 3, randomized, double-blind trial of Pegylated Liposomal Doxorubicin (PLD) plus AMG 386 or placebo in women with recurrent, partially platinum sensitive or resistant epithelial

Final number of patients: 223

Participating groups:

AGO, BGOG, MaNGO, MITO, (DGCG, NCRN)

Closure: 2017

Publications:

• ENGOT-ov-6/TRINOVA-2:  Randomized, Double-Blind, Phase 3 Study of Pegylated Liposomal Doxorubicin Plus Trebananib or Placebo in Women With Recurrent Partially Platinum-Sensitive or Resistant Ovarian Cancer

       European Journal of Cancer 2016 

 

ENGOT-ov5/MaNGO/INOVATYON

Leading group: MaNGO

Clinical Trial Study: Phase III multicenter, randomized study of Trabectedin plus Pegylated Liposomal Doxorubicin (PLD) versus Carboplatin plus PLD in patients with ovarian cancer progressing within 6-12 months of last platinum

Final number of patients: 617

Participating groups:

A-AGO, BGOG, DGOG, GEICO, NCRI, NOGGO, NSGO, SAKK

Closure: 2020

Publications: ESMO 2020

 

ENGOT-ov4/NOGGO/Expression III

Leading group: NOGGO

Clinical Trial Study: Perceptions and expectations on clinical management of ovarian cancer European survey: Expression III

Final number of patients: 1830

Participating groups:

A-AGO, AGO, BGOG, GEIGO, GINECO, MITO

Closure: 2016

Publications: TBA

 

ENGOT-ov3/GINECO/Aurelia

Leading group: GINECO

Clinical Trial Study: Randomized trial comparing chemotherapy with or without bevacizumab in recurrent platin-resitant ovarian cancer

Final number of patients: 360

Participating groups:

AGO, BGOG, DGOG, GEICO, HeCOG, MITO, NSGO

Closure: 2012

Publications:

• Poor concordance between CA-125 and RECIST at the time of disease progression in patients with platinum-resistant ovarian cancer: analysis of the AURELIA trial.

Lindemann K, Kristensen G, Mirza MR, Davies L, Hilpert F, Romero I, Ayhan A, Burges A, Rubio MJ, Raspagliesi F, Huizing M, Creemers GJ, Lykka M, Lee CK, Gebski V, Pujade-Lauraine E.

Ann Oncol. 2016 Aug;27(8):1505-10. doi: 10.1093/annonc/mdw238. Epub 2016 Jul 11.

 

• Prognostic and predictive effects of primary versus secondary platinum resistance for bevacizumab treatment for platinum-resistant ovarian cancer in the AURELIA trial.

Trillsch F, Mahner S, Hilpert F, Davies L, García-Martínez E, Kristensen G, Savarese A, Vuylsteke P, Los M, Zagouri F, Gladieff L, Sehouli J, Khoon Lee C, Gebski V, Pujade-Lauraine E.

Ann Oncol. 2016 Jun 10. pii: mdw236. [Epub ahead of print]

 

• Independent radiologic review of AURELIA, a phase 3 trial of bevacizumab plus chemotherapy for platinum-resistant recurrent ovarian cancer.

Husain A, Wang Y, Hanker LC, Ojeda B, Anttila M, Breda E, Vuylsteke P, Pujade-Lauraine E.

Gynecol Oncol. 2016 Sep;142(3):465-70. doi: 10.1016/j.ygyno.2016.05.011. Epub 2016 Jun 25.

 

• Bevacizumab Combined With Weekly Paclitaxel, Pegylated Liposomal Doxorubicin, or Topotecan in Platinum-Resistant Recurrent Ovarian Cancer: Analysis by Chemotherapy Cohort of the Randomized Phase III AURELIA Trial.

Poveda AM, Selle F, Hilpert F, Reuss A, Savarese A, Vergote I, Witteveen P, Bamias A, Scotto N, Mitchell L, Pujade-Lauraine E.

J Clin Oncol. 2015 Nov 10;33(32):3836-8. doi: 10.1200/JCO.2015.63.1408. Epub 2015 Aug 17. No abstract available.

 

• Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer.

Stockler MR, Hilpert F, Friedlander M, King MT, Wenzel L, Lee CK, Joly F, de Gregorio N, Arranz JA, Mirza MR, Sorio R, Freudensprung U, Sneller V, Hales G, Pujade-Lauraine E.

J Clin Oncol. 2014 May 1;32(13):1309-16. doi: 10.1200/JCO.2013.51.4240. Epub 2014 Mar 31.

 

• Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial.

Pujade-Lauraine E, Hilpert F, Weber B, Reuss A, Poveda A, Kristensen G, Sorio R, Vergote I, Witteveen P, Bamias A, Pereira D, Wimberger P, Oaknin A, Mirza MR, Follana P, Bollag D, Ray-Coquard I.

J Clin Oncol. 2014 May 1;32(13):1302-8. doi: 10.1200/JCO.2013.51.4489. Epub 2014 Mar 17. Erratum in: J Clin Oncol. 2014 Dec 10;32(35):4025

 

ENGOT-ov2/BGOG-ov7/Trinova 3

Leading group: BGOG

Clinical Trial Study: A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers (I. Vergote)

Final number of patients: 1015

Participating groups: A-AGO, AGO, DGOG, GEICO, HeCOG, MaNGO, MITO, NSGO

Closure: 2013

Publications: 

• Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer: a randomised, double-blind, phase 3 trial

Vergote I, Scambia G, O'Malley DM, Van Calster B, Park SY, Del Campo JM, Meier W, Bamias A, Colombo N, Wenham RM, Covens A, Marth C, Raza Mirza M, Kroep JR, Ma H, Pickett CA, Monk BJ; TRINOVA-3/ENGOT-ov2/GOG-3001 investigators

Lancet Oncol. 2019 May 7, DOI:  10.1016/S1470-2045(19)30178-0

 

ENGOT-ov1/MITO-8

Leading group: MITO

Clinical Trial Study: A phase III international multicenter randomized study testing the effect on survival of prolonging platinum-free interval in patients with ovarian cancer recurring between 6 and 12 months after previous platinum based chemotherapy

Final number of patients: 215

Participating groups: 

AGO, BGOG, MaNGO

Closure: 2017

Publications: 

• Randomized Controlled Trial Testing the Efficacy of Platinum-Free Interval Prolongation in Advanced Ovarian Cancer: The MITO-8, MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG Study.

Pignata S, Scambia G, Bologna A, Signoriello S, Vergote IB, Wagner U, Lorusso D, Murgia V, Sorio R, Ferrandina G, Sacco C, Cormio G, Breda E, Cinieri S, Natale D, Mangili G, Pisano C, Cecere SC, Di Napoli M, Salutari V, Raspagliesi F, Arenare L, Bergamini A, Bryce J, Daniele G, Piccirillo MC, Gallo C, Perrone F.

J Clin Oncol. 2017 Aug 21:JCO2017734293. doi: 10.1200/JCO.2017.73.4293. [Epub ahead of print]

 

ENGOT-en9/A-AGO/LEAP-001

Leading group: A-AGO

Clinical Trial Study: A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)

Final number of patients: 844

Participating groups:

BGOG, GEICO, NOGGO, ISGO, MITO, PGOG, CTI, NCRI, TRSGO

Closure: 2020

Publications: TBA

 

ENGOT-en6/NSGO/RUBY (Part I)

Leading group: NSGO

Clinical Trial Study: A phase III, randomized, open-label study of TSR-042, an Anti-PD-1 monoclonal antibody, versus investigator´s choice chemotherapy in patients with advanced/recurrent endometrial cancer

Final number of patients: 470

Participating groups:

BGOG, CEEGOG, DGOG, ISGO

Closure: 2021

Publications: expected in 3Q 2021

 

ENGOT-en4/NCRI/STATEC

Leading group: NCRI

Clinical Trial Study:

STATEC: A randomised trial of non-Selective versus selective adjuvant Therapy in high risk Apparent sTage 1 Endometrial Cancer

Final number of patients: 49

Participating groups:

DGOG, (ANZGOG)

Closure: 2019

Publications: TBA

 

ENGOT-en3/NSGO/PALEO

Leading group: NSGO

Clinical Trial Study: A randomized phase II trial of Palbociclib in combination with letrozole versus letrozole for patients with oestrogen receptor positive recurrent endometrial cancer

Final number of patients: 78

Participating groups:

GEICO, MITO, NOGGO

Closure: 2019

Publications: TBA

 

ENGOT-en2/NSGO/DGCG

Leading group: NSGO

Clinical Trial Study: Adjuvant chemotherapy in node negative endometrial carcinoma

Final number of patients: 237

Participating groups:

BGOG, CEEGOG, GEICO, ISGO, MaNGO, MITO, NOGGO

 

ENGOT-en1/NSGO/FANDANGO

Leading group: NSGO

Clinical Trial Study: A randomized phase II trial of first-line combination chemotherapy with Nintedanib/placebo for patients with advanced or recurrent endometrial cancer

Final number of patients: 149

Participating groups:

BGOG, GINECO, NOGGO

Closure: 2019

Publications: TBA 

 

ENGOT-cx14/CEEGOG/FERTISS

Leading group: CEEGOG

Clinical Trial Study: FERTISS - FERTIility Sparing Surgery in cervical cancer patients (outside trials)

Final Number of patients: 734

Participating groups:

AGO, GINECO, MITO

Closure: 2020

Publications: TBA

 

ENGOT-cx9/GEICO/EMPOWER Cervical-1

Leading group: GEICO

Clinical Trial Study: An open-label, randomized, GOG/ENGOT phase 3 trial of anti-PD1 cemiplimab versus investigator's choice chemotherapy in >2 line recurrent cervical cancer

Final Number of patients: 534

Participating groups:

BGOG, HEGOG, MITO, MaNGO, NCRI, PGOG

Closure: 2021

Publications: ESMO Virtual plenary 2021

 

 

ENGOT-cx8/BGOG-cx8/GCT1015-05

Leading group: BGOG

Clinical Trial Study: A phase 2 open-label trial of Tisotumab Vedotin (HuMax® - TF-ADC) alone or in combination in first line recurrent or stage IVB cervical cancer

Final number of patients: 175

Participating groups: 

CEEGOG, CTI, DGOG, MITO, NCRI, NSGO, SGCTG, TRSGO

Closure: 2020

Publications: TBA

 

ENGOT-cx6/BGOG-cx6/GCT1015-04

Leading group: BGOG

Clinical Trial Study: A single arm, multicenter, international trial of Tisotumab Vedotin (HuMax® - TF-ADC) in previously treated, recurrent or metastatic cervical cancer 

Final Number of patients: 102

Participating groups:

AGO, CEEGOG, GEICO, MITO, NSGO

Closure: 2019

Publications: 

• Manuscript published Lancet Oncology April 2021: Efficacy and safety of tisotumab vedotin in previously treated
  recurrent or metastatic cervical cancer (innovaTV 204/ GOG-3023/ENGOT-cx6): a multicentre, open-label, single-arm, phase 2 study

  Robert L Coleman, Domenica Lorusso, Christine Gennigens, Antonio González-Martín, Leslie Randall, David Cibula, Bente Lund, Linn Woelber,
  Sandro Pignata, Frederic Forget, Andrés Redondo, Signe Diness Vindeløv, Menghui Chen, Jeffrey R Harris, Margaret Smith, Leonardo Viana Nicacio,
  Melinda S L Teng, Annouschka Laenen, Reshma Rangwala, Luis Manso, Mansoor Mirza, Bradley J Monk, Ignace Vergote, on behalf of the
  innovaTV 204/GOG-3023/ENGOT-cx6 Collaborators*

 

ENGOT-cx3/CEEGOG/ABRAX

Leading group: CEEGOG

Clinical Trial Study: Abandoning of radical hysterectomy in cervical cancer - retrospective trial

Final number of patients: 515

Participating groups: 

AGO, BGOG, MITO

Closure: 2019

Publications: 

• ESMO 2020

• Oncologic outcome after completing or abandoning (radical) hysterectomy in patients with cervical cancer and intraoperative detection of lymph node positivity; ABRAX (ABandoning RAd hyst in cerviX cancer).

  Dostalek L, Runnebaum I, Raspagliesi F, et al.  

  Int J Gynecol Cancer. 2020;30(2):261-264. doi:10.1136/ijgc-2019-000890

• Completion of radical hysterectomy does not improve survival of patients with cervical cancer and intraoperatively detected lymph node involvement: ABRAX international retrospective cohort study.
  Eur J Cancer. 2021. PMID: 33290995

 

ENGOT-cx2/CEEGOG/SENTIX

Leading group: CEEGOG

Clinical Trial Study: SENTIX (SENTinel lymph node in cervIX cancer) - a prospective observational trial on sentinel lymph node biopsy in patients with early stage cervical cancer

Final number of patients: 600

Participating groups:

BGOG

Closure: 2019

Publications: 

• A prospective multicentre trial on sentinel lymph node biopsy in patients with early-stage cervical cancer (SENTIX)

Cibula D, Dusek J, Jarkovsky J, Dundr P, Querleu D, van der Zee A, Kucukmetin A, Kocian R.

Int J Gynecol Cancer. 2019 Jan;29(1):212-215

• Central Pathology Review in SENTIX, A Prospective Observational International Study on Sentinel Lymph Node Biopsy in Patients with Early-Stage Cervical Cancer (ENGOT-CX2)

Kristyna Nemejcova, Roman Kocian, Christhardt Kohler, Jiri Jarkovsky, Jaroslav Klat, Alberto Berjon, Radovan Pilka, Borek Sehnal, Blanca Gil-Ibanez, Ezequiel Lupo, Almerinda Petiz, Octavio Arencibia Sanchez, Peter Kascak, Fabio Martinelli, Alessandro Buda, Jiri Presl, Marc Barahona, Luc van Lonkhuijzen, Wiktor Szatkowski, Lubos Minar, Maja Pakiz, Pavel Havelka, Cristina Zorrero, Marcin Misiek, Leon Cornelius Snyman, Dariusz Wydra, Ignace Vergote, Alla Vinnytska, Mikulas Redecha, Martin Michal, Solveig Tingulstad, Barbara Kipp, Grzegorz Szewczyk, Robert Toth, Francisco Javier de Santiago Garcia, Pluvio Jesus Coronado Martin, Robert Poka, Karl Tamussino, Mathieu Luyckx, Maxime Fastrez, Juan Carlos Staringer, Anna Germanova, Andrea Plaikner, Sylva Bajsova, Pavel Dundr, Nina Mallmann-Gottschalk, David Cibula.

Cancers journal (Cancers (Basel). 2020 Apr; 29;12(5): E1115

• Sentinel lymph node mapping and intraoperative assessment in a prospective, international, multicentre, observational trial of patients with cervical cancer: The SENTIX trial

David Cibula, Roman Kocian, Andrea Plaikner, Jiri Jarkovsky, Jaroslav Klat, Ignacio Zapardiel, Radovan Pilka, Aureli Torne, Borek Sehnal, Marcela Ostojich, Almerinda Petiz, Octavio Arencibia Sanchez, Jiri Presl, Alessandro Buda, Francesco Raspagliesi, Peter Kascak, Luc van Lonkhuijzen, Marc Barahona, Lubos Minar, Pawel Blecharz, Maja Pakiz, Dariusz Wydra, Leon Cornelius Snyman, Kamil Zalewski, Cristina Zorrero, Pavel Havelka, Mikulas Redecha, Alla Vinnytska, Ignace Vergote, Solveig Tingulstad, Martin Michal, Barbara Kipp, Jiri Slama, Simone Marnitz, Sylva Bajsova, Alicia Hernandez, Daniela Fischerova, Kristyna Nemejcova, Christhardt Kohler.

Eur J Cancer, 2020 Sep;137:69-80.

• Voiding recovery after radical parametrectomy in cervical cancer patients: An international prospective multicentre trial - SENTIX.

Gynecol Oncol. 2021 Jan 5:S0090-8258(20)34221-9.

 

ENGOT-cx1/BGOG-cx1

Leading group: BGOG

Clinical Trial Study: A randomized phase II trial of paclitaxel-carboplatin 3-weekly with or without Nintedanib (BIBFI 120) in advanced or recurrent cervical carcinoma

Final number of patients: 120

Participating groups:

AGO, GEICO, MaNGO, MITO, NOGGO

Closure: 2018

Publications: TBA 

 

ENGOT-v1/DGOG - GROINSV-2

Leading group: DGOG

Clinical Trial Study: Radiotherapy in vulvar carcinoma with small metastatic sentinel nodes

Final number of patients: 1719

Participating groups: TBA

Closure: 2018

Publications: TBA