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Spots Global Cancer Trial Database for Efficacy Study of Chemotherapy to Treat Ovarian Cancer Recurrence by Prolonging the Platinum Free Interval

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Trial Identification

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

Conditions

Ovarian Cancer

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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