Publications

Published Closed Trials

 

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

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-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

 

 

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-ov4/NOGGO/Expression III

Leading group: NOGGO

Clinical Trial Study: Perceptions and expectations on clinical management of ovarian cancer European survey: Expression III. (J. Sehouli)

Final number of patients: 1830

Participating groups:

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

 

 

ENGOT-ov6/ 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)

 

 

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)

Publications: first presentation planned at ASCO 2018

 

 

ENGOT-ov8/NOGGO

Leading group: NOGGO

Clinical Trial Study: Single arm multicenter phase-II trial for Catumaxomab and chemotherapy in patients with recurrent ovarian cancer to investigate the feasibility and clinical activity of initial IP Catumaxomab followed by chemotherapy regimens. (J. Sehouli)

Final number of patients: 2

Participating groups:

A-AGO, AGO, BGOG, MaNGO, NSGO

Study stopped

 

 

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. (J. Sehouli)

Final number of patients: 174

Participating group: AGO

Closure: 2013

 

 

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

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-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 of Persistent low-grade Serous Carcinomas of the Ovary, Fallopian Tube or Primary Peritoneum. (I. Vergote)

Final number of patients: 341

Participating groups:

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

 

 

ENGOT-ov12/MITO-12

Leading group: MITO

Clinical Trial Study: Pathway to diagnosis of ovarian cancer: an observational retrospective multicentre trial (J. Bryce)

Final number of patients: 700

Participating groups:

BGOG, MaNGO, NOGGO

 

 

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. (Ch. Kurzeder)

Date of activation: 2012 / recruitment closed in September 2014

Final number of patients: 156

Participating groups:

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

Closure: 2016

 

 

ENGOT-ov16/NSGO/NOVA

Leading group: NSGO

Phase 3 Randomized Double-Blind Trial of Maintenance with Niraparib Versus Placebo in Patients with Platinum Sensitive Ovarian Cancer (M. R. Mirza)

Number of patients accrued: 553

Planned number of patients: 360

Participating groups:

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

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-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. (S. Pignata)

Final number of patients: 406

Participating groups:

MaNGO, BGOG, GINECO, HeCOG, SAKK

Closure: 2016

 

 

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)

Publications: Annals of Oncology

 

 

ENGOT-ov21/GINECO/Solo2

Leading group: GINECO

Clinical Trial Study: Phase III Study in BRCAm Platinum Sensitive Relapsed Ovarian Cancer Patients (E. Pujade-Lauraine)

Final number of patients: 295

Participating groups: AGO, BGOG, DGOG, GEICO, ISGO, MaNGO, MITO, NCRI

Closure: 2015

 

 

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

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