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Brief Title: Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval
Official Title: Liposomal Doxorubicin Versus Carboplatin/Paclitaxel in Patients With Ovarian Cancer Recurrence Between 6 and 12 Months After Previous Platinum Based Therapy: Phase III Randomized Multicenter Study Amendment Title Protocol Version 2.0: Phase III International Multicenter Randomized Study Testing the Effect on Survival of Prolonging Platinum-free Interval in Patients With Ovarian Cancer Recurring Between 6 and 12 Months After Previous Platinum Based Chemotherapy.
Study ID: NCT00657878
Brief Summary: This study aims to test the hypothesis that the artificial prolongation of the platinum-free interval with a non-platinum treatment will improve the effectiveness of overall therapy in patients with ovarian cancer progression occurring 6-12 months after first-line treatment with a platinum-derivative.
Detailed Description: Ovarian cancer is the most deadly gynecologic cancer. Though many patients respond well initially to chemotherapy, most of them in time will suffer a relapse. Patients often receive multiple lines of chemotherapy for their recurrences, and the choice of chemotherapy depends largely on the time interval since the last therapy. Patients whose disease recurs longer than 12 months after a platinum containing treatment are considered to be platinum sensitive, and are candidates for retreatment with a platinum regimen. Patients in whom disease recurs less than 6 months after a platinum containing treatment are considered platinum resistant or refractory, and are treated with a non platinum chemotherapy. The option of treatment is less clear for patients whose disease recurs between 6 and 12 months after platinum containing therapy. It is hypothesized that prolonging the interval since last platinum treatment by using a non platinum chemotherapy will result in better outcomes for these patients. This study will evaluate if the experimental sequence of a non platinum based chemotherapy, followed at a later progression by a platinum based chemotherapy is superior, in terms of the effect on overall survival, to the standard inverse sequence of treatment.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
AZ Groeninge, Kortrijk, , Belgium
UZ Gasthusiberg, Leuven, , Belgium
CHC-Clinique St-Joseph, Liège, , Belgium
Clinique & Maternité Sainte-Elisabeth, Namur, , Belgium
AZ Nikolaas, Sint Niklaas, , Belgium
Charité Campus Virchow-Klinkum, Berlin, , Germany
Kliniken essen Mitte-Evang Huyssens Stiftung/Knappschaft, Essen, , Germany
Universitatsklinikum, Essen, , Germany
Universitatsklinikum, Freiburg, , Germany
Gynecology, Albertinen Krankenhaus, Hamburg, , Germany
Universitatskilinikum Schleswig-Holstein, Kiel, , Germany
Frauenklinik, Marburg, , Germany
Klinikum rechts der Isar der Technischen Universitat, Munchen, , Germany
Azienda Ospedaliera V. Cervello, Palermo, PA, Italy
Ospedale S. Massimo, Day Hospital Oncologico, Penne, PE, Italy
Centro di Riferimento Oncologico, Divisione di Oncolgia Medica C, Aviano, PN, Italy
Ospedale Mazzoni, Ascoli Piceno, , Italy
Policlinico Universitario, Bari, , Italy
Universita di Bari Policinico I Clinical Ostetrica e Ginecologica, Bari, , Italy
Ospedale Fatebenefratelli, Benevento, , Italy
Ospedale Senatore Antonio Perrino, Brindisi, , Italy
Universita Cattolica del Sacro Cuore, Campobasso, , Italy
Ospedale Renzetti di Lanciano, Lanciano, , Italy
Ospedale A. Manzoni, Lecco, , Italy
Istituto Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Ospedale San Raffaele, Milano, , Italy
Ospedale S. Gerardo, Monza, , Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico, Napoli, , Italy
Ospedale Silvestrini, Perugia, , Italy
Ospedale Civile S. Spirito, Pescara, , Italy
A.O. Bianchi Melacrino Morelli Ospedale Riuniti, Reggio Calabria, , Italy
Arcispedale S. Maria Nuova, Reggio Emilia, , Italy
Ospedale degli Infermi, U.O. Oncologia Medica, Rimini, , Italy
Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia, Roma, , Italy
Universita Cattolica del Sacro Cuore, Roma, , Italy
A.O. Ordine Mauriziano, Torino, , Italy
Ospedale S. Chiara, Trento, , Italy
A.O. di Udine S. Maria della Misericordia, Udine, , Italy
Ospedale Del Ponte, Varese, , Italy
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
Name: Marilina Piccirillo, M.D.
Affiliation: National Cancer Institute, Naples
Role: PRINCIPAL_INVESTIGATOR
Name: Ciro Gallo, M.D., Ph.D.
Affiliation: University of Campania "Luigi Vanvitelli"
Role: PRINCIPAL_INVESTIGATOR