ONGOING TRIALS – STATUS February 2012
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.
Number of patient accrued: 124
Number of patients needed: 253
Participating member groups: MITO - MaNGO - BGOG - AGO Germany
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
Number of patient accrued: 2
Number of patients needed: 2000
Participating members:BGOG, AGO, A-AGO, DGCG, Gineco, HECOG, NSGO, MITO, MaNGO (and GOG)
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
Number of patients accrued: 1500
Participating groups: NOGGO, AGO, BGOG, MITO, MaNGO, NCRI, Gineco, GEICO
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.
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.
Number of patient accrued: 56
Number of patients needed: 396
Participating member groups: AGO, A-AGO, BGOG, DGCG, MITO, MaNGO, NCRI
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.
Number of patient accrued: 93
Number of patients needed: 184
Participating members: AGO, NOGGO
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
Number of patient accrued: 774
Number of patients needed: 800
Participating members: MITO - MaNGO - Gineco - HECOG
ENGOT-ov12 - Leading group: MITO
Pathway to diagnosis of ovarian cancer : an observational retrospective multicentre trial.
Number of patient accrued: 462
Number of patients needed: -
Participating members: MITO, MaNGO, BGOG
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.
Number of patient accrued: 46
Number of patients needed: 1485
Participating members: NCRI, GEICO, ICORG, SCOTROC
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
Number of patient accrued: 67
Number of patients needed: 796
Participating members: AGO, Gineco, NSGO
ENGOT-EN2/ - Leading group: DGCG
Adjuvant chemotherapy in node negative endometrial carcinoma
Number of patient accrued: 0
Number of patients needed: 678
Participating members: DGCG, NSGO, EORTC, MITO, AGO, A-AGO, NOGGO, BGOG, MaNGO,
Mayo Clinic and Gothic (Japan) will be cooperating.
ENGOT-VI/DGOG - GROINSV-2 - Leading group: DGOG
Radiotherapy in vulvar carcinoma with small metastatic sentinel nodes.
Number of patient accrued: 500 (SN pos and negative)
Number of patients needed: 139 SN positive
Participating members: DGOG, BGOG, DGCG, NCRI, NSGO, GOG
ENGOT-ov20 Desktop 3 - Leading group: AGO
Randomised trial investigating secondary debulking versus no-secondary debulking in platin sensitive disease
Number of patient accrued: 57
Number of patients needed: 367
Participating members:AGO, BGOG, MITO, Gineco
UPCOMING TRIALS
ENGOT-EN1/ - Leading group: DGCG
Replacement needed for “Ixabepilone/carboplatin versus paclitaxel/carboplatin in advanced or recurrent endometrial carcinoma"
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
Number of patient accrued: 0
Number of patients needed: 0
Participating members: NSGO, AGO, EORTC, Gineco, NOGGO
ENGOT-GYN1/NSGO - NCRI
A phase II trial of a triple angiokinase inhibitor (BIBF1120) in the treatment of patients with recurrent clear cell ovarian cancer
Number of patient accrued: 0
Number of patients needed: 80
Participating members: SGCTG (lead group, in cooperation with NSGO), EORTC, Gineco,NSGO
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
Number of patient accrued: 0
Number of patients needed: 112
Participating members: BGOG
ENGOT-ov2a - Leading group: GINECO
Olaparib/paclitaxel-carboplatin versus paclitaxel/carbo as first-line therapy in serous and endometrioid advanced ovarian carcinoma
ENGOT-ov7 - Leading group: NSGO
Olaparib/paclitaxel-carboplatin versus paclitaxel/ carboplatin in platin sensitive recurrent serous and endometrioid ovarian carcinoma
ENGOT-ov8 - Leading group: NOGGO
Multicenter phase-II trial for catumaxomab and chemotherapy in patients with recurrent ovarian cancer
Number of patient accrued: 0
Number of patients needed: 51
Participating members: AGO, A-AGO, BGOG, MaNGO, NSGO
ENGOT-ov13/NCRI/ICON8
Randomised trial of dose-fractionated chemotherapy compared to standard three-weekly chemotherapy, following immediate primary surgery or as part of delayed primary surgery
ENGOT-ov14/ AGO-OVARxx - 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
Number of patient accrued: 0
Number of patients needed: 220
Participating members: AGO, A-AGO, NSGO, DGCG, Gineco, GEICO, GEICO, BGOG, MaNGO, SGCTG, TRSGO
ENGOT-ov16/GINECO - Leading group: GINECO
Olaparib first-line trial : Olaparib/paclitaxel-carboplatin versus paclitaxel/carbo as first-line therapy in serous and endometrioid advanced ovarian cancer
ENGOT-ov17/MITO 16/ MaNGO 2
A multicenter randomised study in patients with epithelial ovarian cancer with Bevacizumab plus chemo versus chemo at progression after first-line chemo plus Bevacizumab
Number of patient accrued: 0
Number of patients needed: 920
Participating members: MITO, MaNGO
ENGOT-ov18/AGO-OVAR-xx
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
Number of patient accrued: 0
Number of patients needed: 1000
Participating members: AGO
ENGOT-ov19a and 19b/GEICO-2a and 2b
Phase III multicenter randomised study of BIBF 1120 versus placebo combined standard chemotherapy (PLD/Carboplatinum) in platinum resistant and platinum -sensitive disease
Number of patient accrued: 0
Number of patients needed: 19a-900, 19b-300
Participating members:GEICO