Spots Global Cancer Trial Database for Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer
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Trial Identification
Brief Title: Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer
Official Title: Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer
Study ID: NCT00054626
Conditions
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy is effective in preventing relapse in patients who have undergone radical cystectomy for bladder cancer. PURPOSE: Phase III trial to compare the effectiveness of cisplatin combined with gemcitabine with that of observation in treating patients with bladder cancer who have undergone surgery to remove the bladder.
Detailed Description: OBJECTIVES: * Compare the overall, cause-specific, and disease-free survival of patients with high-risk muscle-invasive transitional cell carcinoma of the bladder treated with adjuvant cisplatin and gemcitabine vs observation after radical cystectomy. * Compare the dose intensity and toxicity of two different schedules of cisplatin and gemcitabine in these patients. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and disease status (T2 \[G3 only\] or T3-4 \[any G\], N0-2 vs any T, N1-2, M0). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients are further randomized to 1 of 2 treatment regimens. * Regimen A: Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1, 8, and 15. * Regimen B: Patients receive cisplatin IV on day 15 and gemcitabine as in regimen A. Treatment in both regimens repeats every 28 days for 4 courses. * Arm II: Patients undergo observation followed by cisplatin and gemcitabine as in arm I at relapse. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 700 patients (350 per treatment arm) will be accrued for this study within 3 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ospedale Civile Via Caronia, Acireale - CT, , Italy
Ospedale S. Giuseppe, Albano, , Italy
Ospedale San Lazzaro, Alba, , Italy
Ospedale SS. Biagio e Arrigo, Alessandria, , Italy
Ospedale Civile Alessandria, Alessandria, , Italy
Presidio Ospedale, Anagni, , Italy
Istituto Nazionale Riposo e Cura Anziani Istituto, Ancona - AN, , Italy
Ospedale Torrette University Ancona, Ancona, , Italy
Ospedale Generale Umberto 1, Ancona, , Italy
Ospedale S. Donato, Arezzo, , Italy
Ospedale Civile di Asti, Asti, , Italy
S.G. Moscati Hospital, Avellino, , Italy
Ospedale Civile Avezzano, Avezzano, , Italy
Centro di Riferimento Oncologico - Aviano, Aviano, , Italy
Ospedale di Venere - Carbonara, Bari-Carbonara, , Italy
Universita Degli Studi di Bari, Bari, , Italy
Istituto Di Ricovero E Cura A Carattere Scientifico, Bari, , Italy
Ospedale S. Martino, Belluno, , Italy
Ospedali Riuniti di Bergamo, Bergamo, , Italy
Ospedale degli Infermi - ASL 12, Biella, , Italy
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi, Bologna, , Italy
Azienda Sanitaria di Bolzano, Bolzano, , Italy
Ospedale S. Trinita, Borgomanero, , Italy
Spedali Civili di Brescia, Brescia, , Italy
Ospedale di Busto Arsizio, Busto Arsizio, , Italy
Ospedale SS Trinita, Cagliari, , Italy
Ospedale Caltanissetta, Caltanissetta, , Italy
Ospedale Civile Camposanpiero, Camposanpiero, , Italy
Istituto per la Ricerca e Cura del Cancro, Candiolo, , Italy
Civic Hospital of Carrara, Carrara, , Italy
Ospedale S. Spirito, Casale Monferrato, , Italy
Ospedale S. Leonardo, Castellammare di Stabia - NA, , Italy
Ospedale Cannnizzaro, Catania, , Italy
Ospedale S. Luigi, Catania, , Italy
Ospedale Regionale A. Pugliese, Catanzaro, , Italy
Ospedale SS Annunziata, Chieti, , Italy
Universita G.D'Annunzio Di Chieti, Chieti, , Italy
Ospedale Di Cirie, Cirie, , Italy
Ospedale Sant Anna, Como, , Italy
Ospedale Maggiore Crema, Crema, , Italy
Ospedale Civile S. Croce, Fano, , Italy
Ospedale Fidenza, Fidenza, , Italy
Ospendale S.M. Annunziata-A.S.DI Florence, Florence, , Italy
Morgagni-Pierantoni Ospedale, Forli, , Italy
Ospedale S. Sebastiano, Frascati - RM, , Italy
Ospedale Umberto I, Frosinone, , Italy
Ospedale S. Antonio Abate, Gallarate Varese, , Italy
Ospedale Di Gela, Gela - CL, , Italy
Istituto Nazionale per la Ricerca sul Cancro, Genoa, , Italy
Ospedale San Martino, Genoa, , Italy
Presidio Ospedaliero-Gorizia, Gorizia, , Italy
Ospedale Misericordia USL 9, Grosseto, , Italy
INI Grottaferrata, Grottaferrata, , Italy
Ospedale Nuovo, Imola, , Italy
Ospedali Vecchi, Imola, , Italy
Ospedale Civile di Ivrea, Ivrea, , Italy
Ospendale S. Andrea EST, La Spezia, , Italy
Ospedale Civile Lanciano, Lanciano, , Italy
Ospedale Santa Maria Goretti, Latina, , Italy
Ospedale Alessandro Manzoni, Lecco, , Italy
Ospedale Civile di Legnano, Legnano, , Italy
Presidio Ospedaliero di Livorno, Livorno, , Italy
Carlo Poma Hospital, Mantova, , Italy
Ospedale Papardo, Messina, , Italy
Policlinico Messina, Messina, , Italy
University of Milan, Milan, , Italy
Ospedale San Giuseppe, Milan, , Italy
Istituto Scientifico H. San Raffaele, Milan, , Italy
European Institute of Oncology, Milan, , Italy
Ospedale Fatebene Fratelli, Milan, , Italy
Ospedale San Carlo Borromeo, Milan, , Italy
Ospedale Luigi Sacco, Milan, , Italy
Azienda Ospedaliera - Universitaria di Modena, Modena, , Italy
Sant Agostino - Estenes Institutes, Modena, , Italy
Policlinico Monserrato, Monserrato - CA, , Italy
Clinica Urologica II, Monza, , Italy
Ospedale San Gerardo, Monza, , Italy
Azienda Ospedaliera "A. Cardarelli", Naples, , Italy
Federico II University Medical School, Naples, , Italy
Istituto Tumori/Fondazione Pascale, Naples, , Italy
Ospedale Civile Negrar, Negrar, , Italy
Azienda Ospedaliera Maggiore Della Carita, Novara, , Italy
Azienda Ospedale S. Luigi at University of Torino, Orbassano, , Italy
Casa di Cura Noto Pasqualino, Palermo, , Italy
Ospedale Oncology M. Ascoli, Palermo, , Italy
Ospedale La Maddalena - Palermo, Palermo, , Italy
Azienda Ospedaliera Di Parma, Parma, , Italy
Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, , Italy
Universita Degli Studi, Pavia, , Italy
Azienda Ospedale - d "S. Salvatore", Pesaro, , Italy
Ospedale Spiritito Santo, Pescara, , Italy
Ospedale Santa Corona, Pietra Ligure -SV, , Italy
Ospedale Santa Chiara Pisa, Pisa, , Italy
Ospedale Pistoia, Pistoia, , Italy
Azienda Ospedaliera "Santa Maria Degli Angeli", Pordenone, , Italy
Azienda U.S.L. Cesena, Potenza, , Italy
Ospedale Carlo Forlanini, Potenza, , Italy
Ospedale Di Rivoli, Rivoli, , Italy
Azienda Ospedaliera Sant'Andrea, Rome, , Italy
Ospedale C.T.O. Roma, Rome, , Italy
Ospedale Sant' Eugenio, Rome, , Italy
Azienda Ospedaliera S. Camillo-Forlanini, Rome, , Italy
Azienda Policlinico Umberto Primo, Rome, , Italy
Istituto Regina Elena, Rome, , Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore, Rome, , Italy
Fatebenefratelli, Isola Tiberina Hospital, Rome, , Italy
Ospedale San Pietro Fatebenefratelli, Rome, , Italy
Ospedale Civile di Rovigo, Rovigo, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Ospedale Saluzzo, Saluzzo - CN, , Italy
Ospedale San Daniele del Friuli, San Daniele del Friuli, , Italy
Ospedale Casa Sollievo della Sofferenza, San Giovanni - Rotondo, , Italy
ASL NO. 1 Imperiese, San Remo, , Italy
Ospedale Civile G Borea, San Remo, , Italy
Ospedale Civile Di San Vito Al Tagliamento, San Vito Al Talgliamento, , Italy
Az. Ospedale Villa Scassi, Sandpierdarena, , Italy
Istituto Clinica Medica, Sassari, , Italy
Ospedale Civile ASL 1, Sassari, , Italy
Ospedale SS Trinita, Sassari, , Italy
Policlinico Sassari, Sassari, , Italy
Ospedali Savigliano, Savigliano - CN, , Italy
Ospedale S. Paolo Valloria, Savona, , Italy
Ospedale Civile Sestri Levante, Sestri Levante - GE, , Italy
Universita di Siena, Siena, , Italy
Ospedale Umberto 1, Siracusa, , Italy
Osepdale Civile, Sondrio, , Italy
Ospedale SS Trinita, Sora, , Italy
SS Annunziata, Sulmona, , Italy
Ospedale S. Vincenzo, Taormina, , Italy
Ospedale Civile Teramo, Teramo, , Italy
Ospedale Generale Prov. Boldrini, Thiene, , Italy
Ospedale Civile, Tolmezzo Gemona F., , Italy
Ospedale Civile Trapani, Trapani, , Italy
Ospedale Di Trento, Trento, , Italy
Primario U.O. di Oncologia Medica, Trento, , Italy
Ospedale Cattinara, Trieste, , Italy
Ospedale Amedeo Savoia, Turin, , Italy
Ospedale Martini, Turin, , Italy
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino, Turin, , Italy
Ospedale Gradenigo, Turin, , Italy
Ospedale Cottolengo, Turin, , Italy
Ospedale Giovanni Bosco, Turin, , Italy
Ospedale S. Giovanni Vecchio, Turin, , Italy
Azienda Ospedaliera Santa Maria della Misericordia, Udine, , Italy
Ospedale Civile ULSS 12, Venezia, , Italy
Ospedale Civile Verbania, Verbania, , Italy
Ospedal San Andrea, Vercelli, , Italy
Policlinico Borgo Roma, Verona, , Italy
Policlinico G. B. Rossi - Borgo Roma, Verona, , Italy
Ospedale San Bortolo, Vicenza, , Italy
Presidio Ospedaliero Belcolle, Viterbo, , Italy
Contact Details
Name: Camillo F. Pollera, MD
Affiliation: Presidio Ospedaliero Belcolle
Role: STUDY_CHAIR
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