Spots Global Cancer Trial Database for MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: MITO-2: A Study Comparing 2 Chemotherapy Regimens (Carboplatin/Liposomal Doxorubicin vs Carboplatin/Paclitaxel) in Patients With Ovarian Cancer
Official Title: Phase III Randomized Multicentre Trial of Carboplatin + Liposomal Doxorubicin vs Carboplatin + Paclitaxel in Patients With Ovarian Cancer
Study ID: NCT00326456
Conditions
Study Description
Brief Summary: The purpose of this study is to compare the effectiveness (progression free survival) of the experimental combination of carboplatin + liposomal doxorubicin with the standard combination of carboplatin + paclitaxel in first line treatment of patients with ovarian cancer. Secondary objectives are to evaluate overall survival, quality of life, objective response rate, and toxicity.
Detailed Description: Ovarian cancer is the second most frequent and the most deadly gynaecologic cancer. The high mortality rate is due to the late diagnosis of this malignancy that often develops without symptoms, as well as to limited results in treatment of the disease. Patients may respond well initially to chemotherapy, but the vast majority of patients will experience a progression of the disease. The poor long term results in the standard treatment available today for first-line chemotherapy of ovarian cancer make research into new, more beneficial treatment strategies necessary. The proven efficacy of liposomal doxorubicin in second line treatment, where it is the first drug to have shown some significant benefit in terms of survival, and the possibility of easily combining it with full doses and normal use of carboplatin, encourages the testing of the effectiveness of the combination of carboplatin and liposomal doxorubicin in first line treatment. Patients enrolled into this study will be randomly assigned to one of two treatment groups: · Standard therapy consisting of 6 cycles of chemotherapy: * carboplatin AUC 5 given intravenously on day 1 every 3 weeks AND * paclitaxel 175 mg/m2 given intravenously on day 1 every 3 weeks OR · Experimental therapy consisting of 6 cycles of chemotherapy: * carboplatin AUC 5 given intravenously on day 1 every 3 weeks AND * liposomal doxorubicin 30 mg/m2 given intravenously on day 1 every 3 weeks
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Clinica Malzoni, Reparto di Ginecologia Oncologica, Avellino, AV, Italy
Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica, Monteforte Irpino, AV, Italy
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica, Acquaviva delle Fonti, BA, Italy
IRCCS Oncologico Bari, Oncologia Medica, Bari, BA, Italy
Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale, Bari, BA, Italy
Ospedale Riuniti di Bergamo, U.O. di Ostetricia e Ginecologia, Bergamo, BG, Italy
Ospedale Fatebenefratelli, U.O. di Oncologia, Benevento, BN, Italy
Ospedale di Bentivoglio, Bentivoglio, BO, Italy
Ospedale Bellari, U.O. di Oncologia, Bologna, BO, Italy
Ospedale di Budrio, Budrio, BO, Italy
Policlinico Universitario, Oncologia Medica II, Cagliari, CA, Italy
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia, Campobasso, CB, Italy
Ospedale Mariano Santo, U.O. di Oncologia Medica, Cosenza, CS, Italy
Ospedale Cannizzaro, Divisione di Ostetricia e Ginecologia, Catania, CT, Italy
Azienda Ospedaliera Universitaria Acrispedale Sant'Anna, Ferrara, FE, Italy
Ospedale Pierantoni, Divisione di Oncologia Medica, Forli', FO, Italy
Azienda Ospedaliera Carlo Poma, Divisione di Oncologia ed Ematologia, Mantova, MN, Italy
Ospedale Ramazzini, Day Hospital Oncologico, Carpi, MO, Italy
Policlinico Universitario P. Giaccone, Palermo, PA, Italy
Ospedale M. Ascoli, Palermo, PA, Italy
Casa di Cura La Maddalena S.p.A., Dipartimento Oncologico, Palermo, PA, Italy
Ospedale S. Massimo, Day Hospital Oncologico, Penne, PE, Italy
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C, Aviano, PN, Italy
Azienda Ospedaliera S. Maria degli Angeli, Servizio di Oncologia, Pordenone, PN, Italy
Ospedale Civile di Faenza, Divisione di Oncologia Medica, Faenza, RA, Italy
Azienda Ospedaliera Bianchi Melacrino Morelli Ospedale Riuniti, Divisione di Oncologia Medica, Reggio Calabria, RE, Italy
Ospedale degli Infermi, U.O. Oncologia Medica, Rimini, RI, Italy
Ospedale Civile Umberto I, Day Hospital Oncoematologico, Nocera Inferiore, SA, Italy
Ospedale S. Chiara, U.O. di Oncologia Medica, Trento, TN, Italy
Ospedale S. Anna, Day Hospital Oncologico Divisione A, Torino, TO, Italy
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica, Vicenza, VI, Italy
Azienda Ospedaliera D. Cotugno, Napoli, , Italy
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B, Napoli, , Italy
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C, Napoli, , Italy
Istituto Regina Elena, Divisione di Oncologia Medica, Roma, , Italy
Ospedale S. Giovanni Calibita Gatebenefratelli, Roma, , Italy
CHC Maternidade Bissaya-Barreto, Gynecology Unit, Coimbra, , Portugal
Istanbul University Medical Oncology, Istanbul, , Turkey
Contact Details
Name: Sandro Pignata, M.D., Ph.D
Affiliation: National Cancer Institute, Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Perrone, M.D., Ph.D
Affiliation: National Cancer Institute, Naples
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
