ONGOING TRIALS – STATUS April 2013
ENGOT-ov-1/MITO-8 – Leading Group: MITO
Randomized trial of PLD followed by paclitaxel/carboplatin versus paclitaxel/carboplatin followed by PLD in intermediate platin sensitive recurrent ovarian cancer. (S. Pignata)
Number of patient accrued: 147
Number of patients needed: 253
Participating member groups: MITO - MaNGO - BGOG - AGO Germany (no longer recruiting)
ENGOT-ov2/BGOG-ov7 - Leading group: BGOG
AMG386/paclitaxel/carboplatin versus paclitaxel/ carboplatin as first-line therapy in advanced ovarian, peritoneal and fallopian tube cancer. (I. Vergote)
Number of patient accrued: 405
Number of patients needed: 2000
Participating members:BGOG, AGO, A-AGO, GEICO, Gineco, HECOG, NSGO, MITO, MaNGO (and GOG), DGOG
ENGOT- ov5 - Leading group: MaNGO
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. (N. Colombo).
Number of patient accrued: 1
Number of patients needed: 588
Participating members: AGO, MaNGO, EORTC, NOGGO, BGOG, NSGO, GEICO, NCRI, ECOG
ENGOT-ov6 - Leading group: A-AGO
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 Ovarian, Primary Peritoneal, or Fallopian Tube Cancer. (Ch. Marth).
Number of patient accrued: 67
Number of patients needed: 396
Participating member groups: AGO, A-AGO, BGOG, DGCG, MITO, MaNGO, NCRI, Gineco
ENGOT-ov7 - GINECO / Alienor
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.
Number of patient accrued: 1
Number of patients needed: 60
Participating members: Gineco (leading group), AGO
ENGOT-ov8 - Leading group: NOGGO
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)
Date of activation: 2012 Number of patient accrued: 0
Number of patients needed: 51
Participating members: NOGGO, AGO, A-AGO, BGOG, MaNGO, NSGO
ENGOT-ov9 - Leading group: NOGGO
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)
Number of patient accrued: 147
Number of patients needed: 184
Participating members: AGO, NOGGO
ENGOT-ov11 - Leading group: BGOG
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).
Number of patient accrued: 0
Number of patients needed: 300
Leading group: BGOG Groups interested: MITO, MaNGO, Gineco, NOGGO, AGO, A-AGO, NSGO, NOGGO, ISGO
ENGOT-ov12 - Leading group: MITO
Pathway to diagnosis of ovarian cancer : an observational retrospective multicentre trial. (J. Bryce).
Number of patient accrued: 569
Number of patients needed: xxx
Participating members: MITO, MaNGO, BGOG, Gineco, NOGGO
ENGOT-ov 13/ICON8 - Leading group: NCRI
An international multi-stage 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 cancer. (J. Ledermann).
Number of patient accrued: 450
Number of patients needed: 1485
Participating members: NCRI, GEICO, ICORG, SCOTROC, KGOG and Mexico
ENGOT-ov14/ AGO-OVAR 2.20 - Leading group: AGO
A randomised phase II study comparing Caelyx or Topotecan or Gemcitabin with or without Pertuzumab in patients low HER3 mRNA platin-resistant ovarian cancer. (Christian Kurzeder).
Date of activation: 2012 / extended to 2013 Number of patient accrued: 22
Number of patients needed: 220
Participating members: AGO, A-AGO, NSGO, Gineco, GEICO, BGOG, MaNGO, TRSGO
ENGOT-ov15/AGO-OVAR 17 - Leading group: AGO
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. (J. Pfisterer)
Number of patient accrued: 684
Number of patients needed: 900
Participating members: AGO, Gineco, NSGO
ENGOT-ov17/MITO 16
Phase III trial with second line chemotherapy +/- Bevacizumab in patients with platinum sensitive ovarian cnacer recurrence after Bevacizumab and chemotherapy in the first line. (S. Pignata)
Date of activation: 2013 April Number of patient accrued: 0
Number of patients needed: 400
Participating members: MITO (leading), MaNGO, Gineco, HECOG, SAKK
ENGOT-ov18/AGO-OVAR 2.21
In this trial patients with platinum sensitive recurrent ovarian cancer (more than 6 months platinum-free interval) will be randomised between Carbo/Gem with Bevacizumab versus Carbo/Caelyx with Bevacizumab. (J. Pfisterer)
Date of activation: 2013 Number of patient accrued: 0
Number of patients needed: 654
Participating members: AGO, Gineco
ENGOT-ov19 - GEICO
Phase III multicenter randomised study of BIBF 1120 versus placebo combined standard chemotherapy (PLD/Carboplatinum) in platinum resistant and platinum -sensitive disease (Jose Maria del Campo)
Date of activation: 2013 Number of patient accrued: 600
Number of patients needed: 900
Participating members:GEICO, NSGO, GOG, Gineco, BGOG, MaNGO, MITO, NCRI, DGOG
ENGOT-ov20 Desktop 3 - Leading group: AGO
Randomised trial investigating secondary debulking versus no-secondary debulking in platin sensitive disease. (A. du Bois)
Number of patient accrued: 164
Number of patients needed: 367
Participating members:AGO, A-AGO, BGOG, MITO, Gineco, NSGO, GEICO, NCRI, SGCTG (KGOG)
ENGOT-EN1-I - Leading group: NSGO
Randomized phase II trial of first-line combination chemotherapy with BIBFI 120 or placebo for patients with advanced or reccurrent cancer. (Mansoor Raza Mirza)
Number of patient accrued: 0
Number of patients needed: 150
Leading group: NSGO Groups interested: MITO, Gineco, NOGGO, AGO, EORTC, BGOG
ENGOT-EN2 - Leading group: DGCG
Adjuvant chemotherapy in node negative endometrial carcinoma. (Mansoor Raza Mirza)
Number of patient accrued: 14
Number of patients needed: 678 Leading group: DGCG
Participating members: DGCG, NSGO, EORTC, MITO, AGO, A-AGO, NOGGO, BGOG, MaNGO, DGOG
Mayo Clinic and Gothic (Japan) will be cooperating.
ENGOT-GYN1 / SGCTG - NSGO
A phase II trial of a triple angiokinase inhibitor (BIBF1120) in the treatment of patients with recurrent clear cell ovarian cancer. (Mansoor Raza Mirza)
Date of activation: 2013 Number of patient accrued: 0
Number of patients needed: 90
Participating members: SGCTG (lead group, in cooperation with NSGO), NCRI, EORTC, GINECO
ENGOT-VI/DGOG - GROINSV-2 - Leading group: DGOG
Radiotherapy in vulvar carcinoma with small metastatic sentinel nodes. (A. van der Zee)
Number of patient accrued: 794 (SN pos and negative)
Number of patients needed: 138 SN positive
Participating members: DGOG, BGOG, NCRI, NSGO, GOG
ENGOT-Cx/BGOG-cxI
A randomized phase II trial of paclitaxel-carboplatin 3-weekly with or without Nintedanib (BIBFI 120) in advanced or recurrent cervical cancer. (I. Vergote)
Date of activation: Q1 / 2013 Number of patient accrued: 0
Number of patients needed: 120
Participating members: BGOG, MITO, Gineco, GEICO, NCRI, MaNGO
PAST TRIALS
ENGOT-ov-3/ Aurelia – Leading group: GINECO
Randomized trial comparing chemotherapy with or without bevacizumab in recurrent platin-resitant ovarian cancer.
Number of patient accrued: 360
Number of patients needed: 360
Participating members: Gineco, AGO, BGOG, DGCG, GEICO, MITO, NSGO, HECOG
Closure: 4/2012
ENGOT-ov-4 – Leading group: NOGGO
Perceptions and expectations on clinical management of ovarian cancer European survey: Expression III. (J. Sehouli).
Number of patients accrued: 1776 (closed)
Participating groups: NOGGO, AGO, BGOG, MITO, MaNGO, NCRI, Gineco, GEICO
ENGOT-ov-10/MITO-7 - Leading group: MITO
First line weekly carboplatin and paclitaxel vs every 3 weeks carboplatin/paclitaxel in patients with ovarian cancer: Phase III multicenter trial. (S. Pignata)
Number of patient accrued: 824 (closed)
Number of patients needed: 800
Participating members: MITO - MaNGO - Gineco - HECOG