Spots Global Cancer Trial Database for Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab
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Trial Identification
Brief Title: Study of Clinical and Biological Prognostic Factors in Patients With Ovarian Cancer Receiving Carboplatin +Paclitaxel With Bevacizumab
Official Title: A MULTICENTER STUDY IN PATIENTS WITH STAGE III-IV EPITHELIAL OVARIAN CANCER TREATED WITH CARBOPLATIN/PACLITAXEL WITH BEVACIZUMAB: CLINICAL AND BIOLOGICAL PROGNOSTIC FACTORS
Study ID: NCT01706120
Conditions
Study Description
Brief Summary: The addition of bevacizumab to first-line chemotherapy has been shown to improve progression free survival for patients with ovarian cancer. The purpose of this study is to explore the potential role of clinical and biologic factors in identifying those patients who benefit most from this combined therapy in terms of progression free and overall survival.
Detailed Description: MITO-16 - MANGO-OV2 is a single-arm, open-label, non-comparative, multicenter, phase IV study. Patients will receive a combination of bevacizumab, paclitaxel and carboplatin as first line treatment (in-label dose and scheduling). This is an exploratory study attempting to identify potential prognostic clinical factors(such as hypertension) and prognostic biologic factors. Overall, 2 types of biomarkers are considered. Dynamic biomarkers are those expressing the changing nature of the disease in relation to the treatment or simply the tumour progression, these are typically not inherited. Genetic biomarkers are typically inherited and are expression of some characteristics potentially able to interfere with the treatment effect (i.e. Pharmacogenomics). The safety of this regimen in routine clinical practice will also be described.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
A.S.O. SS Antonio e Biagio e Cesare Arrigo, Alessandria, , Italy
Centro di Riferimento Oncologico, Aviano, , Italy
Ospedale Fatebenefratelli, Benevento, , Italy
Spedali Civili - Università di Brescia, Brescia, , Italy
Ospedale Senatore Antonio Perrino, Brindisi, , Italy
Fondazione del Piemonte per l'Oncologia, Candiolo, , Italy
Ospedale Ramazzini di Carpi /Ospedale di Mirandola, Carpi, , Italy
Azienda Ospedaliera Garibaldi Nesimadi Catania, Catania, , Italy
Ospedale Cannizzaro, Catania, , Italy
Ospedale Mater Domini, Catanzaro, , Italy
Ospedale Civile di Faenza, Faenza, , Italy
Ospedale Santa Croce, Fano, , Italy
A.O.U. Arcispedale Sant'Anna di Ferrara, Ferrara, , Italy
Ospedale Fabrizio Spaziani di Frosinone / Osp. SS Trinità di Sora, Frosinone, , Italy
E.O. Ospedali Galliera, Genova, , Italy
IRCCS San Martino IST, Genova, , Italy
Ospedale di Guastalla, Guastalla, , Italy
Ospedale A. Manzoni, Lecco, , Italy
Ospedale Mater Salutis, Legnago, , Italy
Presidio Ospedaliero Manerbio, Manerbio, , Italy
A.O. C. Poma, Mantova, , Italy
Istituto Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Istituto Nazionale Tumori, MIlano, , Italy
Ospedale San Raffaele, Milano, , Italy
U.L.S.S. 13, Mirano, , Italy
A.O.U. Policlinico Modena, Modena, , Italy
Ospedale S. Gerardo, Monza, , Italy
AOU Policlinico Federico II, Napoli, , Italy
Istituto Nazionale dei Tumori, Napoli, , Italy
Istituto Sacro Cuore Don Calabria, Negrar, , Italy
Istituto Oncologico Veneto, Padova, , Italy
Fondazione IRCCS S. Matteo, Pavia, , Italy
Ospedale Silvestrini, Perugia, , Italy
Ospedale Santa Chiara, Pisa, , Italy
A.O. Santa Maria degli Angeli, Pordenone, , Italy
Ospedale S. Maria delle Croci, Ravenna, , Italy
Arcispedale S. Maria Nuova, Reggio Emilia, , Italy
Ospedale degli Infermi / Ospedale Civile, Rimini, , Italy
Istituto Regina Elena, Roma, , Italy
Ospedale S. Giovanni Calibita Fatebenefratelli, Roma, , Italy
Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore, Roma, , Italy
A.O. Ordine Mauriziano, Torino, , Italy
A.O.U. OIRM-S. Anna, Torino, , Italy
ASS N 1 Triestina, Trieste, , Italy
A.O. di Udine S. Maria delle Misericordia, Udine, , Italy
Ospedale del Ponte, Varese, , Italy
Contact Details
Name: Sandro Pignata, M.D., Ph.D.
Affiliation: National Cancer Institute, Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Nicoletta Colombo, M.D.
Affiliation: European Institute of Oncology
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Perrone, M.D., Ph.D.
Affiliation: National Cancer Institute, Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Gennaro Daniele, M.D., Ph.D.
Affiliation: National Cancer Institute, Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Roldano Fossati, M.D.
Affiliation: Mario Negri Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Ciro Gallo, M.D.
Affiliation: University of Campania "Luigi Vanvitelli"
Role: PRINCIPAL_INVESTIGATOR
Name: Irene Floriani, Ph.D.
Affiliation: Mario Negri Institute
Role: PRINCIPAL_INVESTIGATOR
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