Spots Global Cancer Trial Database for INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer
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Trial Identification
Brief Title: INOVATYON STUDY -International, Randomized Study in Patients With Ovarian Cancer
Official Title: Phase III International, 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
Study ID: NCT01379989
Conditions
Study Description
Brief Summary: The objective of this multicentric, randomised, Phase III study is to demonstrate superiority, in terms of survival, of trabectedin and Pegylated Liposomal Doxorubicin (PLD) versus carboplatin and PLD in partially-platinum sensitive ovarian cancer patients.
Detailed Description: Patients will be randomised to: Arm A: PLD 30 mg/m2 and carboplatin AUC 5; Arm B: PLD 30 mg/m2 and trabectedin 1.1 mg/m2. Patients' characteristics: patients over 18 years of age with advanced, progressive ovarian cancer 6-12 months after completion of first line or second line treatment with platinum-based chemotherapy.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Krankenhaus Der Barmherzigen Brueder, Graz, AT, Austria
Univ. Clinic for Gynaecology and Obstetrics - Medical University of Innsbruck, Innsbruck, AT, Austria
Medizinische Universitat Graz, Graz, , Austria
Univ. Klinik Frauenheilkunde AKH, Wien, , Austria
Imeldaziekenhuis, Bonheiden, BE, Belgium
AZ Klina, Brasschaat, BE, Belgium
Antwerp University Hospital, Edegem, BE, Belgium
UZ Leuven, Leuven, BE, Belgium
CMSE Clinique et MaternitĂŠ Sainte-Elisabeth, Namur, BE, Belgium
Az Damiaan, Oostende, BE, Belgium
Centrum Voor Oncologie, Turnhout, BE, Belgium
Centre Hospitalier Peltzer La Tourelle (CHPLT), Verviers, BE, Belgium
CHU Dinant Godinne / UCL Namur, Yvoir, BE, Belgium
AZ Maria Middelares, Gent, , Belgium
UZ Gent, Gent, , Belgium
Odense University Hospital, Odense, DK, Denmark
Tampere University Hospital, Tampere, FI, Finland
Kuopio University Hospital - Kuopio, Kuopio, , Finland
Oulu University Hospital, Oulu, , Finland
Charite Universitaetsmedizin, Berlin, DE, Germany
Ev. Waldkrankenhaus Spandau, Berlin, DE, Germany
Praxis Dr. med. JĂśrg Schilling, Berlin, DE, Germany
Praxisklinik Krebsheilkunde fĂźr Frauen, Berlin, DE, Germany
Vivantes Netzwerk fĂźr Gesundheit GmbH, Berlin, DE, Germany
University Hospital Dresden, Dresden, DE, Germany
Dr. med. Georg Heinrich Schwerpunktpraxis fßr Gynäkologische Onkologie, Fßrstenwalde, DE, Germany
Kath. Marienkrankenhaus, Hamburg, DE, Germany
Universitäts - Frauenklinik -Tßbingen, Heidelberg, DE, Germany
Helios Klinikum Krefeld, Krefeld, DE, Germany
"Universitätsklinikum Schleswig-Holstein, Lßbeck, DE, Germany
Staedtisches Klinikum Brandenburg, Brandenburg an der Havel, , Germany
Universitatsfrauenklinik Dusseldorf, Dusseldorf, , Germany
Kliniken Essen Mitte Evang. Huyssens Stiftung, Essen, , Germany
University Medical Center Hamburg, Hamburg, , Germany
Universitaetsklinikum Jena, Jena, , Germany
Klinikum Leverkusen gGmbH, Leverkusen, , Germany
Studienzentrum Onkologie, Ravensburg, , Germany
UFK am Klinikum Suedstadt Rostock, Rostock, , Germany
Onkologische Schwerpunktpraxis, Speyer, , Germany
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, AL, Italy
Ospedale Regionale Umberto Parini, Aosta, AO, Italy
"Ospedale Degli Infermi - Biella", Biella, BI, Italy
Policlinico S.Orsola Malpighi, Bologna, BO, Italy
P.O. "A.Perrino" ASL Brindisi, Brindisi, BR, Italy
A.O. Spedali Civili di Brescia, Brescia, BS, Italy
Fondazione Poliambulanza, Brescia, BS, Italy
Azienda Ospedaliera S. Croce e Carle, Cuneo, CN, Italy
Ospedale Valduce, Como, CO, Italy
Azienda Ospedaliero Universitaria "Policlinico- Vittorio Emanuele" P.O. Gaspare Rodolico, Catania, CT, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) - IRCCS, Meldola e Cesena, Meldola, FC, Italy
Ospedale San Giuseppe - Azienda USL11, Empoli, FI, Italy
Ospedale SS TrinitĂ - Sora, Sora, FR, Italy
Ente Ospedaliero Ospedali Galliera, Genova, GE, Italy
IRCCS San Martino IST - Genova, Genova, GE, Italy
AO della Provincia di Lecco - Ospedale Alessandro Manzoni, Lecco, LC, Italy
Ospedale Vito Fazzi, Lecce, LE, Italy
European Institute of Oncology, Department of Surgery Science, Milan, MI, Italy
Azienda Ospedaliero Universitaria Policlinico di Modena, Modena, MO, Italy
AO Ospedali Riuniti Villa Sofia Cervello, Palermo, PA, Italy
Ospedale Guglielmo da Saliceto - Piacenza, Piacenza, PC, Italy
Istituto Oncologico Veneto, Padova, PD, Italy
Ospedale Santa Chiara, Pisa, PI, Italy
Nuovo Ospedale di Prato S. Stefano, Prato, PO, Italy
Istituto di Ricovero e Cura a Carattere Scientifico - Centro Regionale Oncologico Basilicata, Rionero in Vulture, PZ, Italy
Ospedale di Faenza, Faenza, RA, Italy
Ospedale Umberto I, Lugo, RA, Italy
Azienda Ospedaliera "Bianchi - Melacrino - Morelli", Reggio Calabria, RC, Italy
IRCCS - Arcispedale S. Maria Nuova, Reggio Emilia, RE, Italy
Policlinico Umberto I, UniversitĂ di Roma "La Sapienza", Roma, RM, Italy
Ospedale Infermi, Rimini, RN, Italy
Ospedale Civile di Sondrio, Sondrio, SO, Italy
Ospedale di Santa Chiara, Trento, TN, Italy
Fondazione Piemontese Per L'Oncologia - IRCCS, Candiolo, Candiolo, TO, Italy
AOU CittĂ della salute e della scienza - OIRM S. Anna, Torino, TO, Italy
Ospedale Mauriziano, Torino, TO, Italy
Azienda Ospedaliero Universitaria CittĂ Della Salute e Della Scienza di Torino - P.O. S. Anna, Torino, TO, Italy
Ospedale Del Ponte - Varese, Varese, VA, Italy
U.L.S.S. 13 Mirano - Dolo - Noale, Mirano, VE, Italy
Sacro Cuore Don Calabria, Negrar, VR, Italy
AOU Materdomini, Catanzaro, , Italy
UniversitĂ degli Studi di Napoli Federico II, Napoli, , Italy
AOU Maggiore della CaritĂ , Novara, , Italy
Presidio Ospedaliero A Tortora, Pagani, , Italy
ARNAS Civico, Palermo, , Italy
Casa di Cura La Maddalena, Palermo, , Italy
Ospedale S. Vincenzo, Taormina, , Italy
ASL VC Ospedale S. Andrea - Vercelli, Vercelli, , Italy
Radboud University Medical Centre, Nijmegen, NL, Netherlands
Radium Hospitalet Oslo University Hospital, Oslo, , Norway
Stavanger University Hospital, Stavanger, , Norway
University Hospital of North Norway, Tromsø, , Norway
Hospital General Universitario de Elche, Alicante, ES, Spain
Hospital Germans Trias I Pujol, Badalona, ES, Spain
Institut Català d´Oncologia, Hospitalet - Hospitalet de Llobregat, Barcellona, ES, Spain
Consorcio Hospitalario Provincial de Castellon, Castèllo, ES, Spain
Institut CatalĂ d'Oncologia de Girona, Girona, ES, Spain
H. U. Arnau de Vilanova, Lleida, ES, Spain
MD Anderson Cancer Center, Madrid, ES, Spain
Althaia, Manresa, ES, Spain
Hospital Universitario J.M. Morales Meseguer, Murcia, ES, Spain
Hospital Son Espases, Palma de Mallorca, ES, Spain
Hospital Son Llatzer, Palma de Mallorca, ES, Spain
Complejo Hospitalario de Navarra, Pamplona, ES, Spain
Corporacion Sanitaria y Universitaria Parc Tauli, Sabadell, ES, Spain
Hospital Universitario Donostia - San Sebastian, San Sebastian, ES, Spain
Hospital General Universitario de Valencia, Valencia, ES, Spain
Hospital La Fe, Valencia, ES, Spain
IVO Instituto Valenciano de Oncologia, Valencia, ES, Spain
Hospital Reina Sofia, Cordoba, , Spain
Hospital Clinico Universitario Virgen De La Arrixaca, El Palmar, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Consorci Sanitari De Terrassa, Terrassa, , Spain
Hospital Lluis Alcanyis Xativa, Valencia, , Spain
Hospital Universitario Dr Peset, Valencia, , Spain
Kantonsspital Aarau, Aarau, CH, Switzerland
Frauenklinik -Universitätsspital Basel, Basel, CH, Switzerland
Klinik Engeried, Bern, CH, Switzerland
Universitätsklinik fßr Frauenheilkunde, Universitätsklinik fßr Onkologische Medizin - Inselspital, Bern, CH, Switzerland
Kantonsspital GraubĂźnden, Chur, CH, Switzerland
Kantonsspital Frauenfeld, Frauenfeld, CH, Switzerland
Luzerner Kantonsspital, Luzern, CH, Switzerland
Kantonsspital MĂźnsterlingen, MĂźnsterlingen, CH, Switzerland
Kantonsspital Olten, Olten, CH, Switzerland
Kantonsspital St. Gallen, St. Gallen, CH, Switzerland
Kantonsspital, Winterthur, CH, Switzerland
Frauenklinik - Stadtspital Triemli, ZĂźrich, CH, Switzerland
Ospedale Regionale Bellinzona e Valli - Istituto Oncologico Della Svizzera Italiana (IOSI), Bellinzona, TI, Switzerland
Royal Sussex County Hospital, Brighton, , United Kingdom
Velindre Cancer Center, Cardiff, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
The Churchill Hospital, Oxford, , United Kingdom
Worthingh Hospital, Worthing, , United Kingdom
Contact Details
Name: Nicoletta Colombo, MD
Affiliation: European Institute of Oncology (I.E.O), Milan, Italy
Role: PRINCIPAL_INVESTIGATOR
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