Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer
NCT ID: NCT00054626
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
700 participants
INTERVENTIONAL
2001-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
cisplatin
gemcitabine hydrochloride
adjuvant therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Histologically confirmed transitional cell carcinoma of the bladder
* T2 (G3 only) or T3-4 (any G), N0-2 or any T, N1-2, M0
* No secondary localization
* Radical cystectomy (without residual disease) performed within 10 weeks prior to study entry to include:
* Men: Cystectomy with removal of prostate and seminal vesicles including 1.5 cm of urethra plus pelvic lymphadenectomy (at least 15 negative lymph nodes are recommended to define as N0)
* Women: Cystectomy with complete removal of the bladder, uterus, ovaries, and anterior walls of the vagina plus pelvic lymphadenectomy
PATIENT CHARACTERISTICS:
Age
* 18 to 74
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC at least 3,500/mm\^3
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic
* Bilirubin less than upper normal limit (ULN)
* Gamma-GT less than ULN
* SGOT and SGPT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
Renal
* Creatinine no greater than1.25 times ULN
* Creatinine clearance at least 60 mL/min
Cardiovascular
* No congestive heart failure
* No angina pectoris
* No cardiac arrhythmia
* No uncontrolled arterial hypertension
* No history of acute myocardial infarction within the past year
Other
* No other serious concurrent illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior systemic chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* Palliative radiotherapy allowed at relapse for symptomatic bone metastases
Surgery
* See Disease Characteristics
18 Years
74 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
OTHER_GOV
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Camillo F. Pollera, MD
Role: STUDY_CHAIR
Presidio Ospedaliero Belcolle
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ospedale Civile Via Caronia
Acireale - CT, , Italy
Ospedale San Lazzaro
Alba, , Italy
Ospedale S. Giuseppe
Albano Laziale, , Italy
Ospedale SS. Biagio e Arrigo
Alessandria, , Italy
Ospedale Civile Alessandria
Alessandria, , Italy
Presidio Ospedale
Anagni, , Italy
Ospedale Torrette University Ancona
Ancona, , Italy
Ospedale Generale Umberto 1
Ancona, , Italy
Istituto Nazionale Riposo e Cura Anziani Istituto
Ancona - AN, , 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
Universita Degli Studi di Bari
Bari, , Italy
Istituto Di Ricovero E Cura A Carattere Scientifico
Bari, , Italy
Ospedale di Venere - Carbonara
Bari-Carbonara, , 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
Cirié, , 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
Forlì, , 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
Ospedale Civile Di San Vito Al Tagliamento
San Vito Al Talgliamento, , Italy
Az. Ospedale Villa Scassi
Sandpierdarena, , Italy
ASL NO. 1 Imperiese
Sanremo, , Italy
Ospedale Civile G Borea
Sanremo, , 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
Osepdale Civile
Sondrio, , Italy
Ospedale SS Trinita
Sora, , Italy
SS Annunziata
Sulmona, , Italy
Ospedale Umberto 1
Syracuse, , 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pollera CF, Merendino N, Cianciulli AM, et al.: Preliminary cytogenetic and pharmacogenomic analysis of muscle-invasive transitional-cell carcinoma (TCC) of the bladder in patients (pts) enrolled in the Italian National Research Council (CNR) phase III randomized trial comparing adjuvant cisplatin-gemcitabine (PG) vs observation (OBS) after radical cystectomy. [Abstract] J Clin Oncol 23 (Suppl 16): A-4589, 400s, 2005.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ITNRC-CU02.00447ST/97
Identifier Type: -
Identifier Source: secondary_id
NCI-V02-1715
Identifier Type: -
Identifier Source: secondary_id
CDR0000258426
Identifier Type: -
Identifier Source: org_study_id