Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer

NCT00054626 | Unknown Phase 3

• 3 other identifiers: CDR0000258426ITNRC-CU02.00447ST/97NCI-V02-1715
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 151

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.

Conditions

Bladder Cancer

Keywords

stage II bladder cancer; stage III bladder cancer; stage IV bladder cancer; transitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (1)

• Overall survival at 5 years

Secondary Outcomes (6)

• Disease-free survival at 5 years

• Local disease-free survival at 5 years

• Distant disease-free survival at 5 years

• Toxicity by WHO system grading after each course

• Quality of life after each course and every 6 months during follow-up

Interventions

cisplatin DRUG

gemcitabine hydrochloride DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: lead

Study Sites (151)

Ospedale Civile Via Caronia

Acireale - CT, 95024, Italy

Location

Ospedale San Lazzaro

Alba, 12051, Italy

Location

Ospedale S. Giuseppe

Albano Laziale, 00041, Italy

Location

Ospedale SS. Biagio e Arrigo

Alessandria, 15100, Italy

Location

Ospedale Civile Alessandria

Alessandria, I-15100, Italy

Location

Presidio Ospedale

Anagni, 03012, Italy

Location

Ospedale Torrette University Ancona

Ancona, 60020, Italy

Location

Ospedale Generale Umberto 1

Ancona, 60100, Italy

Location

Istituto Nazionale Riposo e Cura Anziani Istituto

Ancona - AN, 60100, Italy

Location

Ospedale S. Donato

Arezzo, 52100, Italy

Location

Ospedale Civile di Asti

Asti, 14100, Italy

Location

S.G. Moscati Hospital

Avellino, 83100, Italy

Location

Ospedale Civile Avezzano

Avezzano, 67051, Italy

Location

Centro di Riferimento Oncologico - Aviano

Aviano, 33081, Italy

Location

Universita Degli Studi di Bari

Bari, 70124, Italy

Location

Istituto Di Ricovero E Cura A Carattere Scientifico

Bari, 70126, Italy

Location

Ospedale di Venere - Carbonara

Bari-Carbonara, 70100, Italy

Location

Ospedale S. Martino

Belluno, 32100, Italy

Location

Ospedali Riuniti di Bergamo

Bergamo, 24100, Italy

Location

Ospedale degli Infermi - ASL 12

Biella, 13900, Italy

Location

Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi

Bologna, 40138, Italy

Location

Azienda Sanitaria di Bolzano

Bolzano, 39100, Italy

Location

Ospedale S. Trinita

Borgomanero, 28021, Italy

Location

Spedali Civili di Brescia

Brescia, 25124, Italy

Location

Ospedale di Busto Arsizio

Busto Arsizio, 21052, Italy

Location

Ospedale SS Trinita

Cagliari, 09100, Italy

Location

Ospedale Caltanissetta

Caltanissetta, 93100, Italy

Location

Ospedale Civile Camposanpiero

Camposanpiero, 35012, Italy

Location

Istituto per la Ricerca e Cura del Cancro

Candiolo, 10060, Italy

Location

Civic Hospital of Carrara

Carrara, I-54033, Italy

Location

Ospedale S. Spirito

Casale Monferrato, 15033, Italy

Location

Ospedale S. Leonardo

Castellammare Di Stabia - NA, 80053, Italy

Location

Ospedale Cannnizzaro

Catania, 95100, Italy

Location

Ospedale S. Luigi

Catania, 95100, Italy

Location

Ospedale Regionale A. Pugliese

Catanzaro, 88100, Italy

Location

Ospedale SS Annunziata

Chieti, 66100, Italy

Location

Universita G.D'Annunzio Di Chieti

Chieti, 66100, Italy

Location

Ospedale Di Cirie

Cirié, 10073, Italy

Location

Ospedale Sant Anna

Como, 22100, Italy

Location

Ospedale Maggiore Crema

Crema, 26013, Italy

Location

Ospedale Civile S. Croce

Fano, 61032, Italy

Location

Ospedale Fidenza

Fidenza, 43036, Italy

Location

Ospendale S.M. Annunziata-A.S.DI Florence

Florence, I-50011, Italy

Location

Morgagni-Pierantoni Ospedale

Forlì, 47100, Italy

Location

Ospedale S. Sebastiano

Frascati - RM, 00044, Italy

Location

Ospedale Umberto I

Frosinone, 03100, Italy

Location

Ospedale S. Antonio Abate

Gallarate Varese, 21013, Italy

Location

Ospedale Di Gela

Gela - CL, 930123, Italy

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

Location

Ospedale San Martino

Genoa, 16132, Italy

Location

Presidio Ospedaliero-Gorizia

Gorizia, 34170, Italy

Location

Ospedale Misericordia USL 9

Grosseto, 58100, Italy

Location

INI Grottaferrata

Grottaferrata, 00046, Italy

Location

Ospedale Nuovo

Imola, 40026, Italy

Location

Ospedali Vecchi

Imola, 40026, Italy

Location

Ospedale Civile di Ivrea

Ivrea, 10015, Italy

Location

Ospendale S. Andrea EST

La Spezia, 19100, Italy

Location

Ospedale Civile Lanciano

Lanciano, 66034, Italy

Location

Ospedale Santa Maria Goretti

Latina, 04100, Italy

Location

Ospedale Alessandro Manzoni

Lecco, 23900, Italy

Location

Ospedale Civile di Legnano

Legnano, 20025, Italy

Location

Presidio Ospedaliero di Livorno

Livorno, 57100, Italy

Location

Carlo Poma Hospital

Mantova, 46100, Italy

Location

Ospedale Papardo

Messina, 98100, Italy

Location

Policlinico Messina

Messina, 98123, Italy

Location

University of Milan

Milan, 20122, Italy

Location

Ospedale San Giuseppe

Milan, 20123, Italy

Location

Istituto Scientifico H. San Raffaele

Milan, 20132, Italy

Location

European Institute of Oncology

Milan, 20141, Italy

Location

Ospedale Fatebene Fratelli

Milan, 20152, Italy

Location

Ospedale San Carlo Borromeo

Milan, 20153, Italy

Location

Ospedale Luigi Sacco

Milan, 20157, Italy

Location

Azienda Ospedaliera - Universitaria di Modena

Modena, 41100, Italy

Location

Sant Agostino - Estenes Institutes

Modena, 41100, Italy

Location

Policlinico Monserrato

Monserrato - CA, 09042, Italy

Location

Clinica Urologica II

Monza, 20052, Italy

Location

Ospedale San Gerardo

Monza, 20052, Italy

Location

Azienda Ospedaliera "A. Cardarelli"

Naples, 80127, Italy

Location

Federico II University Medical School

Naples, 80131, Italy

Location

Istituto Tumori/Fondazione Pascale

Naples, 80131, Italy

Location

Ospedale Civile Negrar

Negrar, 37024, Italy

Location

Azienda Ospedaliera Maggiore Della Carita

Novara, 28100, Italy

Location

Azienda Ospedale S. Luigi at University of Torino

Orbassano, 10043, Italy

Location

Casa di Cura Noto Pasqualino

Palermo, 90100, Italy

Location

Ospedale Oncology M. Ascoli

Palermo, 90100, Italy

Location

Ospedale La Maddalena - Palermo

Palermo, Italy

Location

Azienda Ospedaliera Di Parma

Parma, 43100, Italy

Location

Fondazione I.R.C.C.S. Policlinico San Matteo

Pavia, 27100, Italy

Location

Universita Degli Studi

Pavia, 27100, Italy

Location

Azienda Ospedale - d "S. Salvatore"

Pesaro, 61100, Italy

Location

Ospedale Spiritito Santo

Pescara, 65100, Italy

Location

Ospedale Santa Corona

Pietra Ligure -SV, 17029, Italy

Location

Ospedale Santa Chiara Pisa

Pisa, I-56126, Italy

Location

Ospedale Pistoia

Pistoia, 51100, Italy

Location

Azienda Ospedaliera "Santa Maria Degli Angeli"

Pordenone, 33170, Italy

Location

Azienda U.S.L. Cesena

Potenza, 85100, Italy

Location

Ospedale Carlo Forlanini

Potenza, 85100, Italy

Location

Ospedale Di Rivoli

Rivoli, 10098, Italy

Location

Azienda Ospedaliera Sant'Andrea

Rome, 00100, Italy

Location

Ospedale C.T.O. Roma

Rome, 00100, Italy

Location

Ospedale Sant' Eugenio

Rome, 00144, Italy

Location

Azienda Ospedaliera S. Camillo-Forlanini

Rome, 00151, Italy

Location

Azienda Policlinico Umberto Primo

Rome, 00161, Italy

Location

Istituto Regina Elena

Rome, 00161, Italy

Location

Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

Rome, 00168, Italy

Location

Fatebenefratelli, Isola Tiberina Hospital

Rome, 00186, Italy

Location

Ospedale San Pietro Fatebenefratelli

Rome, 00189, Italy

Location

Ospedale Civile di Rovigo

Rovigo, 45100, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Ospedale Saluzzo

Saluzzo - CN, 12037, Italy

Location

Ospedale San Daniele del Friuli

San Daniele del Friuli, 33038, Italy

Location

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

Ospedale Civile Di San Vito Al Tagliamento

San Vito Al Talgliamento, Italy

Location

Az. Ospedale Villa Scassi

Sandpierdarena, 16100, Italy

Location

ASL NO. 1 Imperiese

Sanremo, 18038, Italy

Location

Ospedale Civile G Borea

Sanremo, 18038, Italy

Location

Istituto Clinica Medica

Sassari, 07100, Italy

Location

Ospedale Civile ASL 1

Sassari, 07100, Italy

Location

Ospedale SS Trinita

Sassari, 07100, Italy

Location

Policlinico Sassari

Sassari, 07100, Italy

Location

Ospedali Savigliano

Savigliano - CN, 12038, Italy

Location

Ospedale S. Paolo Valloria

Savona, 17100, Italy

Location

Ospedale Civile Sestri Levante

Sestri Levante - GE, 16039, Italy

Location

Universita di Siena

Siena, 53100, Italy

Location

Osepdale Civile

Sondrio, 23100, Italy

Location

Ospedale SS Trinita

Sora, 03039, Italy

Location

SS Annunziata

Sulmona, 67039, Italy

Location

Ospedale Umberto 1

Syracuse, 95100, Italy

Location

Ospedale S. Vincenzo

Taormina, 98039, Italy

Location

Ospedale Civile Teramo

Teramo, 64100, Italy

Location

Ospedale Generale Prov. Boldrini

Thiene, 36016, Italy

Location

Ospedale Civile

Tolmezzo Gemona F., 33013, Italy

Location

Ospedale Civile Trapani

Trapani, 91100, Italy

Location

Ospedale Di Trento

Trento, 38100, Italy

Location

Primario U.O. di Oncologia Medica

Trento, 38100, Italy

Location

Ospedale Cattinara

Trieste, Italy

Location

Ospedale Amedeo Savoia

Turin, 10100, Italy

Location

Ospedale Martini

Turin, 10100, Italy

Location

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

Turin, 10126, Italy

Location

Ospedale Gradenigo

Turin, 10153, Italy

Location

Ospedale Cottolengo

Turin, Italy

Location

Ospedale Giovanni Bosco

Turin, Italy

Location

Ospedale S. Giovanni Vecchio

Turin, Italy

Location

Azienda Ospedaliera Santa Maria della Misericordia

Udine, 33100, Italy

Location

Ospedale Civile ULSS 12

Venezia, 30100, Italy

Location

Ospedale Civile Verbania

Verbania, 28900, Italy

Location

Ospedal San Andrea

Vercelli, 13100, Italy

Location

Policlinico Borgo Roma

Verona, 37134, Italy

Location

Policlinico G. B. Rossi - Borgo Roma

Verona, 37134, Italy

Location

Ospedale San Bortolo

Vicenza, 36100, Italy

Location

Presidio Ospedaliero Belcolle

Viterbo, I-01100, Italy

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cisplatin; Gemcitabine; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Camillo F. Pollera, MD

  Presidio Ospedaliero Belcolle

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 5, 2003
• First Posted: February 6, 2003
• Study Start: September 1, 2001
• Primary Completion: June 1, 2008
• Last Updated: December 18, 2013

Record last verified: 2008-11

Locations

IT (151)