Publications/Closed Trials (as of April 2018)

 

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: 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: end 2018

 

 

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

 

 

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-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:

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.

 

 

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-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: TBA

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: TBA

Publications: TBA

 

 

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: 618

Participating groups:

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

Closure: TBA

Publications: TBA

 

 

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:

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.

 

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]

 

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.

 

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.

 

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.

 

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: TBA

 

 

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]

 

 

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