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Brief Title: Study Comparing Weekly Versus Every 3 Week Chemotherapy in Patients With Ovarian Cancer
Official Title: Weekly Versus Every 3 Week Carboplatin and Paclitaxel in Patients With Ovarian Cancer: a Phase III Randomized Multicenter Study
Study ID: NCT00660842
Brief Summary: The purpose of this study is to study efficacy and the effects on quality of life in women with ovarian cancer treated with a weekly schedule of chemotherapy with carboplatin and paclitaxel compared to those treated with standard every 3 weeks schedule of the same chemotherapy.
Detailed Description: The standard first-line treatment of ovarian cancer is combination chemotherapy with carboplatin and paclitaxel, given every 3 weeks. Researchers are looking at new ways of giving chemotherapy to make it more tolerable and more effective. One way is by giving the chemotherapy more often in smaller doses. This approach can be associated with fewer or less troubling side effects. Some chemotherapy drugs such as paclitaxel have been shown to also be more active when given once a week rather than once every 3 week schedule.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
IRCCS Oncologico Bari, Oncologia Medica, 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
Azienda Ospedaliera G. Rummo, Benevento, BN, Italy
Università Cattolica del Sacro Cuore, Dipartimento di Oncologia, Campobasso, CB, Italy
Azienda Ospedaliera C. Poma, Mantova, MN, Italy
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 S. Chiara, Trento, TN, Italy
Ospedale S. Bortolo ULSS 6, U.O. di Oncologia Medica, Vicenza, VI, 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 A. Manzoni, Lecco, , Italy
Istituto Nazionale Tumori, Milano, , Italy
A.O. Univeristaria Policlinico, Modena, , Italy
Azienda Ospedaliera D. Cotugno, Napoli, , Italy
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Uro-Ginecologico, Napoli, , Italy
Università Federico II, Cattedra di Oncologia Medica, Napoli, , Italy
Ospedale Silvestrini, Perugia, , Italy
Ospedale Civile S. Spirito, Pescara, , Italy
A.O. S. Maria degli Angeli, Pordenone, , Italy
Ospedale S. Giovanni Calibita Fatebenefratelli, UO di Oncologia, Roma, , Italy
A.O. di Udine S. Maria della Misericordia, Udine, , 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