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| Sponsor: | National Research Council, Italy |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00054626 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer |
Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: adjuvant therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer |
| Estimated Enrollment: | 700 |
| Study Start Date: | September 2001 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Treatment in both regimens repeats every 28 days for 4 courses.
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| Ages Eligible for Study: | 18 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma of the bladder
Radical cystectomy (without residual disease) performed within 10 weeks prior to study entry to include:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations
Hide Study Locations| Italy | |
| ASL NO. 1 Imperiese | |
| San Remo, Italy, 18038 | |
| Az. Ospedale Villa Scassi | |
| Sandpierdarena, Italy, 16100 | |
| Azienda Ospedale - d "S. Salvatore" | |
| Pesaro, Italy, 61100 | |
| Azienda Ospedale S. Luigi at University of Torino | |
| Orbassano, Italy, 10043 | |
| Azienda Ospedaliera - Universitaria di Modena | |
| Modena, Italy, 41100 | |
| Azienda Ospedaliera "A. Cardarelli" | |
| Naples, Italy, 80127 | |
| Azienda Ospedaliera "Santa Maria Degli Angeli" | |
| Pordenone, Italy, 33170 | |
| Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi | |
| Bologna, Italy, 40138 | |
| Azienda Ospedaliera Di Parma | |
| Parma, Italy, 43100 | |
| Azienda Ospedaliera Maggiore Della Carita | |
| Novara, Italy, 28100 | |
| Azienda Ospedaliera S. Camillo-Forlanini | |
| Rome, Italy, 00151 | |
| Azienda Ospedaliera Sant'Andrea | |
| Rome, Italy, 00100 | |
| Azienda Ospedaliera Santa Maria della Misericordia | |
| Udine, Italy, 33100 | |
| Azienda Policlinico Umberto Primo | |
| Rome, Italy, 00161 | |
| Azienda Sanitaria di Bolzano | |
| Bolzano, Italy, 39100 | |
| Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | |
| Turin, Italy, 10126 | |
| Azienda U.S.L. Cesena | |
| Potenza, Italy, 85100 | |
| Carlo Poma Hospital | |
| Mantova, Italy, 46100 | |
| Casa di Cura Noto Pasqualino | |
| Palermo, Italy, 90100 | |
| Centro di Riferimento Oncologico - Aviano | |
| Aviano, Italy, 33081 | |
| Civic Hospital of Carrara | |
| Carrara, Italy, I-54033 | |
| Clinica Urologica II | |
| Monza, Italy, 20052 | |
| European Institute of Oncology | |
| Milan, Italy, 20141 | |
| Fatebenefratelli, Isola Tiberina Hospital | |
| Rome, Italy, 00186 | |
| Federico II University Medical School | |
| Naples, Italy, 80131 | |
| Fondazione I.R.C.C.S. Policlinico San Matteo | |
| Pavia, Italy, 27100 | |
| INI Grottaferrata | |
| Grottaferrata, Italy, 00046 | |
| Istituto Clinica Medica | |
| Sassari, Italy, 07100 | |
| Istituto Clinico Humanitas | |
| Rozzano, Italy, 20089 | |
| Istituto Di Ricovero E Cura A Carattere Scientifico | |
| Bari, Italy, 70126 | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa, Italy, 16132 | |
| Istituto Nazionale Riposo e Cura Anziani Istituto | |
| Ancona - AN, Italy, 60100 | |
| Istituto per la Ricerca e Cura del Cancro | |
| Candiolo, Italy, 10060 | |
| Istituto Regina Elena | |
| Rome, Italy, 00161 | |
| Istituto Scientifico H. San Raffaele | |
| Milan, Italy, 20132 | |
| Istituto Tumori/Fondazione Pascale | |
| Naples, Italy, 80131 | |
| Morgagni-Pierantoni Ospedale | |
| Forli, Italy, 47100 | |
| Osepdale Civile | |
| Sondrio, Italy, 23100 | |
| Ospedal San Andrea | |
| Vercelli, Italy, 13100 | |
| Ospedale S. Donato | |
| Arezzo, Italy, 52100 | |
| Ospedale Alessandro Manzoni | |
| Lecco, Italy, 23900 | |
| Ospedale Amedeo Savoia | |
| Turin, Italy, 10100 | |
| Ospedale C.T.O. Roma | |
| Rome, Italy, 00100 | |
| Ospedale Caltanissetta | |
| Caltanissetta, Italy, 93100 | |
| Ospedale Cannnizzaro | |
| Catania, Italy, 95100 | |
| Ospedale Carlo Forlanini | |
| Potenza, Italy, 85100 | |
| Ospedale Casa Sollievo della Sofferenza | |
| San Giovanni - Rotondo, Italy, 71013 | |
| Ospedale Cattinara | |
| Trieste, Italy | |
| Ospedale Civile Alessandria | |
| Alessandria, Italy, I-15100 | |
| Ospedale Civile ASL 1 | |
| Sassari, Italy, 07100 | |
| Ospedale Civile Avezzano | |
| Avezzano, Italy, 67051 | |
| Ospedale Civile Camposanpiero | |
| Camposanpiero, Italy, 35012 | |
| Ospedale Civile di Asti | |
| Asti, Italy, 14100 | |
| Ospedale Civile di Ivrea | |
| Ivrea, Italy, 10015 | |
| Ospedale Civile di Legnano | |
| Legnano, Italy, 20025 | |
| Ospedale Civile di Rovigo | |
| Rovigo, Italy, 45100 | |
| Ospedale Civile Di San Vito Al Tagliamento | |
| San Vito Al Talgliamento, Italy | |
| Ospedale Civile G Borea | |
| San Remo, Italy, 18038 | |
| Ospedale Civile Lanciano | |
| Lanciano, Italy, 66034 | |
| Ospedale Civile Negrar | |
| Negrar, Italy, 37024 | |
| Ospedale Civile S. Croce | |
| Fano, Italy, 61032 | |
| Ospedale Civile Sestri Levante | |
| Sestri Levante - GE, Italy, 16039 | |
| Ospedale Civile Teramo | |
| Teramo, Italy, 64100 | |
| Ospedale Civile Trapani | |
| Trapani, Italy, 91100 | |
| Ospedale Civile ULSS 12 | |
| Venezia, Italy, 30100 | |
| Ospedale Civile Verbania | |
| Verbania, Italy, 28900 | |
| Ospedale Civile Via Caronia | |
| Acireale - CT, Italy, 95024 | |
| Ospedale Civile | |
| Tolmezzo Gemona F., Italy, 33013 | |
| Ospedale Cottolengo | |
| Turin, Italy | |
| Ospedale degli Infermi - ASL 12 | |
| Biella, Italy, 13900 | |
| Ospedale di Busto Arsizio | |
| Busto Arsizio, Italy, 21052 | |
| Ospedale Di Cirie | |
| Cirie, Italy, 10073 | |
| Ospedale Di Gela | |
| Gela - CL, Italy, 930123 | |
| Ospedale Di Rivoli | |
| Rivoli, Italy, 10098 | |
| Ospedale Di Trento | |
| Trento, Italy, 38100 | |
| University of Milan | |
| Milan, Italy, 20122 | |
| Ospedale Fatebene Fratelli | |
| Milan, Italy, 20152 | |
| Ospedale Fidenza | |
| Fidenza, Italy, 43036 | |
| Ospedale Generale Prov. Boldrini | |
| Thiene, Italy, 36016 | |
| Ospedale Generale Umberto 1 | |
| Ancona, Italy, 60100 | |
| Ospedale Giovanni Bosco | |
| Turin, Italy | |
| Ospedale Gradenigo | |
| Turin, Italy, 10153 | |
| Ospedale La Maddalena - Palermo | |
| Palermo, Italy | |
| Ospedale Luigi Sacco | |
| Milan, Italy, 20157 | |
| Ospedale Maggiore Crema | |
| Crema, Italy, 26013 | |
| Ospedale Martini | |
| Turin, Italy, 10100 | |
| Ospedale Misericordia USL 9 | |
| Grosseto, Italy, 58100 | |
| Ospedale Nuovo | |
| Imola, Italy, 40026 | |
| Ospedale Oncology M. Ascoli | |
| Palermo, Italy, 90100 | |
| Ospedale Papardo | |
| Messina, Italy, 98100 | |
| Ospedale Pistoia | |
| Pistoia, Italy, 51100 | |
| Ospedale Regionale A. Pugliese | |
| Catanzaro, Italy, 88100 | |
| Ospedale S. Leonardo | |
| Castellammare di Stabia - NA, Italy, 80053 | |
| Ospedale S. Antonio Abate | |
| Gallarate Varese, Italy, 21013 | |
| Ospedale S. Giovanni Vecchio | |
| Turin, Italy | |
| Ospedale S. Giuseppe | |
| Albano, Italy, 00041 | |
| Ospedale S. Luigi | |
| Catania, Italy, 95100 | |
| Ospedale S. Martino | |
| Belluno, Italy, 32100 | |
| Ospedale S. Paolo Valloria | |
| Savona, Italy, 17100 | |
| Ospedale S. Sebastiano | |
| Frascati - RM, Italy, 00044 | |
| Ospedale S. Spirito | |
| Casale Monferrato, Italy, 15033 | |
| Ospedale S. Trinita | |
| Borgomanero, Italy, 28021 | |
| Ospedale S. Vincenzo | |
| Taormina, Italy, 98039 | |
| Ospedale Saluzzo | |
| Saluzzo - CN, Italy, 12037 | |
| Ospedale San Bortolo | |
| Vicenza, Italy, 36100 | |
| Ospedale San Carlo Borromeo | |
| Milan, Italy, 20153 | |
| Ospedale San Daniele del Friuli | |
| San Daniele del Friuli, Italy, 33038 | |
| Ospedale San Gerardo | |
| Monza, Italy, 20052 | |
| Ospedale San Giuseppe | |
| Milan, Italy, 20123 | |
| Ospedale San Lazzaro | |
| Alba, Italy, 12051 | |
| Ospedale San Martino | |
| Genoa, Italy, 16132 | |
| Ospedale San Pietro Fatebenefratelli | |
| Rome, Italy, 00189 | |
| Ospedale Sant Anna | |
| Como, Italy, 22100 | |
| Ospedale Sant' Eugenio | |
| Rome, Italy, 00144 | |
| Ospedale Santa Chiara Pisa | |
| Pisa, Italy, I-56126 | |
| Ospedale Santa Corona | |
| Pietra Ligure -SV, Italy, 17029 | |
| Ospedale Santa Maria Goretti | |
| Latina, Italy, 04100 | |
| Ospedale Spiritito Santo | |
| Pescara, Italy, 65100 | |
| Ospedale SS Annunziata | |
| Chieti, Italy, 66100 | |
| Ospedale SS Trinita | |
| Sassari, Italy, 07100 | |
| Ospedale SS Trinita | |
| Cagliari, Italy, 09100 | |
| Ospedale SS Trinita | |
| Sora, Italy, 03039 | |
| Ospedale SS. Biagio e Arrigo | |
| Alessandria, Italy, 15100 | |
| Ospedale Torrette University Ancona | |
| Ancona, Italy, 60020 | |
| Ospedale Umberto 1 | |
| Siracusa, Italy, 95100 | |
| Ospedale Umberto I | |
| Frosinone, Italy, 03100 | |
| Ospedali Riuniti di Bergamo | |
| Bergamo, Italy, 24100 | |
| Ospedali Savigliano | |
| Savigliano - CN, Italy, 12038 | |
| Ospedali Vecchi | |
| Imola, Italy, 40026 | |
| Ospendale S. Andrea EST | |
| La Spezia, Italy, 19100 | |
| Ospendale S.M. Annunziata-A.S.DI Florence | |
| Florence, Italy, I-50011 | |
| Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | |
| Rome, Italy, 00168 | |
| Policlinico Borgo Roma | |
| Verona, Italy, 37134 | |
| Policlinico G. B. Rossi - Borgo Roma | |
| Verona, Italy, 37134 | |
| Policlinico Messina | |
| Messina, Italy, 98123 | |
| Policlinico Monserrato | |
| Monserrato - CA, Italy, 09042 | |
| Policlinico Sassari | |
| Sassari, Italy, 07100 | |
| Presidio Ospedale | |
| Anagni, Italy, 03012 | |
| Presidio Ospedaliero Belcolle | |
| Viterbo, Italy, I-01100 | |
| Presidio Ospedaliero di Livorno | |
| Livorno, Italy, 57100 | |
| Presidio Ospedaliero-Gorizia | |
| Gorizia, Italy, 34170 | |
| Primario U.O. di Oncologia Medica | |
| Trento, Italy, 38100 | |
| S.G. Moscati Hospital | |
| Avellino, Italy, 83100 | |
| Sant Agostino - Estenes Institutes | |
| Modena, Italy, 41100 | |
| Spedali Civili di Brescia | |
| Brescia, Italy, 25124 | |
| SS Annunziata | |
| Sulmona, Italy, 67039 | |
| Universita Degli Studi di Bari | |
| Bari, Italy, 70124 | |
| Universita Degli Studi | |
| Pavia, Italy, 27100 | |
| Universita di Siena | |
| Siena, Italy, 53100 | |
| Universita G.D'Annunzio Di Chieti | |
| Chieti, Italy, 66100 | |
| Ospedale di Venere - Carbonara | |
| Bari-Carbonara, Italy, 70100 | |
| Study Chair: | Camillo F. Pollera, MD | Presidio Ospedaliero Belcolle |
More Information
| Study ID Numbers: | CDR0000258426, ITNRC-CU02.00447ST/97, NCI-V02-1715 |
| Study First Received: | February 5, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00054626 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II bladder cancer stage III bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Urinary Bladder Diseases Physiological Effects of Drugs Urinary Bladder Neoplasms Adjuvants, Immunologic Enzyme Inhibitors Urogenital Neoplasms |
Urologic Neoplasms Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Urologic Diseases Cisplatin Therapeutic Uses Gemcitabine |
