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

Primary Purpose

Bladder Cancer

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
cisplatin
gemcitabine hydrochloride
adjuvant therapy
Sponsored by
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Civile Via Caronia
  • Ospedale S. Giuseppe
  • Ospedale San Lazzaro
  • Ospedale SS. Biagio e Arrigo
  • Ospedale Civile Alessandria
  • Presidio Ospedale
  • Istituto Nazionale Riposo e Cura Anziani Istituto
  • Ospedale Torrette University Ancona
  • Ospedale Generale Umberto 1
  • Ospedale S. Donato
  • Ospedale Civile di Asti
  • S.G. Moscati Hospital
  • Ospedale Civile Avezzano
  • Centro di Riferimento Oncologico - Aviano
  • Ospedale di Venere - Carbonara
  • Universita Degli Studi di Bari
  • Istituto Di Ricovero E Cura A Carattere Scientifico
  • Ospedale S. Martino
  • Ospedali Riuniti di Bergamo
  • Ospedale degli Infermi - ASL 12
  • Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
  • Azienda Sanitaria di Bolzano
  • Ospedale S. Trinita
  • Spedali Civili di Brescia
  • Ospedale di Busto Arsizio
  • Ospedale SS Trinita
  • Ospedale Caltanissetta
  • Ospedale Civile Camposanpiero
  • Istituto per la Ricerca e Cura del Cancro
  • Civic Hospital of Carrara
  • Ospedale S. Spirito
  • Ospedale S. Leonardo
  • Ospedale Cannnizzaro
  • Ospedale S. Luigi
  • Ospedale Regionale A. Pugliese
  • Ospedale SS Annunziata
  • Universita G.D'Annunzio Di Chieti
  • Ospedale Di Cirie
  • Ospedale Sant Anna
  • Ospedale Maggiore Crema
  • Ospedale Civile S. Croce
  • Ospedale Fidenza
  • Ospendale S.M. Annunziata-A.S.DI Florence
  • Morgagni-Pierantoni Ospedale
  • Ospedale S. Sebastiano
  • Ospedale Umberto I
  • Ospedale S. Antonio Abate
  • Ospedale Di Gela
  • Istituto Nazionale per la Ricerca sul Cancro
  • Ospedale San Martino
  • Presidio Ospedaliero-Gorizia
  • Ospedale Misericordia USL 9
  • INI Grottaferrata
  • Ospedale Nuovo
  • Ospedali Vecchi
  • Ospedale Civile di Ivrea
  • Ospendale S. Andrea EST
  • Ospedale Civile Lanciano
  • Ospedale Santa Maria Goretti
  • Ospedale Alessandro Manzoni
  • Ospedale Civile di Legnano
  • Presidio Ospedaliero di Livorno
  • Carlo Poma Hospital
  • Ospedale Papardo
  • Policlinico Messina
  • University of Milan
  • Ospedale San Giuseppe
  • Istituto Scientifico H. San Raffaele
  • European Institute of Oncology
  • Ospedale Fatebene Fratelli
  • Ospedale San Carlo Borromeo
  • Ospedale Luigi Sacco
  • Azienda Ospedaliera - Universitaria di Modena
  • Sant Agostino - Estenes Institutes
  • Policlinico Monserrato
  • Clinica Urologica II
  • Ospedale San Gerardo
  • Azienda Ospedaliera "A. Cardarelli"
  • Federico II University Medical School
  • Istituto Tumori/Fondazione Pascale
  • Ospedale Civile Negrar
  • Azienda Ospedaliera Maggiore Della Carita
  • Azienda Ospedale S. Luigi at University of Torino
  • Casa di Cura Noto Pasqualino
  • Ospedale Oncology M. Ascoli
  • Ospedale La Maddalena - Palermo
  • Azienda Ospedaliera Di Parma
  • Fondazione I.R.C.C.S. Policlinico San Matteo
  • Universita Degli Studi
  • Azienda Ospedale - d "S. Salvatore"
  • Ospedale Spiritito Santo
  • Ospedale Santa Corona
  • Ospedale Santa Chiara Pisa
  • Ospedale Pistoia
  • Azienda Ospedaliera "Santa Maria Degli Angeli"
  • Azienda U.S.L. Cesena
  • Ospedale Carlo Forlanini
  • Ospedale Di Rivoli
  • Azienda Ospedaliera Sant'Andrea
  • Ospedale C.T.O. Roma
  • Ospedale Sant' Eugenio
  • Azienda Ospedaliera S. Camillo-Forlanini
  • Azienda Policlinico Umberto Primo
  • Istituto Regina Elena
  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
  • Fatebenefratelli, Isola Tiberina Hospital
  • Ospedale San Pietro Fatebenefratelli
  • Ospedale Civile di Rovigo
  • Istituto Clinico Humanitas
  • Ospedale Saluzzo
  • Ospedale San Daniele del Friuli
  • Ospedale Casa Sollievo della Sofferenza
  • ASL NO. 1 Imperiese
  • Ospedale Civile G Borea
  • Ospedale Civile Di San Vito Al Tagliamento
  • Az. Ospedale Villa Scassi
  • Istituto Clinica Medica
  • Ospedale Civile ASL 1
  • Ospedale SS Trinita
  • Policlinico Sassari
  • Ospedali Savigliano
  • Ospedale S. Paolo Valloria
  • Ospedale Civile Sestri Levante
  • Universita di Siena
  • Ospedale Umberto 1
  • Osepdale Civile
  • Ospedale SS Trinita
  • SS Annunziata
  • Ospedale S. Vincenzo
  • Ospedale Civile Teramo
  • Ospedale Generale Prov. Boldrini
  • Ospedale Civile
  • Ospedale Civile Trapani
  • Ospedale Di Trento
  • Primario U.O. di Oncologia Medica
  • Ospedale Cattinara
  • Ospedale Amedeo Savoia
  • Ospedale Martini
  • Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
  • Ospedale Gradenigo
  • Ospedale Cottolengo
  • Ospedale Giovanni Bosco
  • Ospedale S. Giovanni Vecchio
  • Azienda Ospedaliera Santa Maria della Misericordia
  • Ospedale Civile ULSS 12
  • Ospedale Civile Verbania
  • Ospedal San Andrea
  • Policlinico Borgo Roma
  • Policlinico G. B. Rossi - Borgo Roma
  • Ospedale San Bortolo
  • Presidio Ospedaliero Belcolle

Outcomes

Primary Outcome Measures

Overall survival at 5 years

Secondary Outcome Measures

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
Dose intensity at the end of the treatment

Full Information

First Posted
February 5, 2003
Last Updated
December 17, 2013
Sponsor
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT00054626
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 Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2001 (undefined)
Primary Completion Date
June 2008 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Overall survival at 5 years
Secondary Outcome Measure Information:
Title
Disease-free survival at 5 years
Title
Local disease-free survival at 5 years
Title
Distant disease-free survival at 5 years
Title
Toxicity by WHO system grading after each course
Title
Quality of life after each course and every 6 months during follow-up
Title
Dose intensity at the end of the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camillo F. Pollera, MD
Organizational Affiliation
Presidio Ospedaliero Belcolle
Official's Role
Study Chair
Facility Information:
Facility Name
Ospedale Civile Via Caronia
City
Acireale - CT
ZIP/Postal Code
95024
Country
Italy
Facility Name
Ospedale S. Giuseppe
City
Albano
ZIP/Postal Code
00041
Country
Italy
Facility Name
Ospedale San Lazzaro
City
Alba
ZIP/Postal Code
12051
Country
Italy
Facility Name
Ospedale SS. Biagio e Arrigo
City
Alessandria
ZIP/Postal Code
15100
Country
Italy
Facility Name
Ospedale Civile Alessandria
City
Alessandria
ZIP/Postal Code
I-15100
Country
Italy
Facility Name
Presidio Ospedale
City
Anagni
ZIP/Postal Code
03012
Country
Italy
Facility Name
Istituto Nazionale Riposo e Cura Anziani Istituto
City
Ancona - AN
ZIP/Postal Code
60100
Country
Italy
Facility Name
Ospedale Torrette University Ancona
City
Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Ospedale Generale Umberto 1
City
Ancona
ZIP/Postal Code
60100
Country
Italy
Facility Name
Ospedale S. Donato
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Ospedale Civile di Asti
City
Asti
ZIP/Postal Code
14100
Country
Italy
Facility Name
S.G. Moscati Hospital
City
Avellino
ZIP/Postal Code
83100
Country
Italy
Facility Name
Ospedale Civile Avezzano
City
Avezzano
ZIP/Postal Code
67051
Country
Italy
Facility Name
Centro di Riferimento Oncologico - Aviano
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Ospedale di Venere - Carbonara
City
Bari-Carbonara
ZIP/Postal Code
70100
Country
Italy
Facility Name
Universita Degli Studi di Bari
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Istituto Di Ricovero E Cura A Carattere Scientifico
City
Bari
ZIP/Postal Code
70126
Country
Italy
Facility Name
Ospedale S. Martino
City
Belluno
ZIP/Postal Code
32100
Country
Italy
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Ospedale degli Infermi - ASL 12
City
Biella
ZIP/Postal Code
13900
Country
Italy
Facility Name
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Sanitaria di Bolzano
City
Bolzano
ZIP/Postal Code
39100
Country
Italy
Facility Name
Ospedale S. Trinita
City
Borgomanero
ZIP/Postal Code
28021
Country
Italy
Facility Name
Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25124
Country
Italy
Facility Name
Ospedale di Busto Arsizio
City
Busto Arsizio
ZIP/Postal Code
21052
Country
Italy
Facility Name
Ospedale SS Trinita
City
Cagliari
ZIP/Postal Code
09100
Country
Italy
Facility Name
Ospedale Caltanissetta
City
Caltanissetta
ZIP/Postal Code
93100
Country
Italy
Facility Name
Ospedale Civile Camposanpiero
City
Camposanpiero
ZIP/Postal Code
35012
Country
Italy
Facility Name
Istituto per la Ricerca e Cura del Cancro
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Facility Name
Civic Hospital of Carrara
City
Carrara
ZIP/Postal Code
I-54033
Country
Italy
Facility Name
Ospedale S. Spirito
City
Casale Monferrato
ZIP/Postal Code
15033
Country
Italy
Facility Name
Ospedale S. Leonardo
City
Castellammare di Stabia - NA
ZIP/Postal Code
80053
Country
Italy
Facility Name
Ospedale Cannnizzaro
City
Catania
ZIP/Postal Code
95100
Country
Italy
Facility Name
Ospedale S. Luigi
City
Catania
ZIP/Postal Code
95100
Country
Italy
Facility Name
Ospedale Regionale A. Pugliese
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Ospedale SS Annunziata
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Universita G.D'Annunzio Di Chieti
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Ospedale Di Cirie
City
Cirie
ZIP/Postal Code
10073
Country
Italy
Facility Name
Ospedale Sant Anna
City
Como
ZIP/Postal Code
22100
Country
Italy
Facility Name
Ospedale Maggiore Crema
City
Crema
ZIP/Postal Code
26013
Country
Italy
Facility Name
Ospedale Civile S. Croce
City
Fano
ZIP/Postal Code
61032
Country
Italy
Facility Name
Ospedale Fidenza
City
Fidenza
ZIP/Postal Code
43036
Country
Italy
Facility Name
Ospendale S.M. Annunziata-A.S.DI Florence
City
Florence
ZIP/Postal Code
I-50011
Country
Italy
Facility Name
Morgagni-Pierantoni Ospedale
City
Forli
ZIP/Postal Code
47100
Country
Italy
Facility Name
Ospedale S. Sebastiano
City
Frascati - RM
ZIP/Postal Code
00044
Country
Italy
Facility Name
Ospedale Umberto I
City
Frosinone
ZIP/Postal Code
03100
Country
Italy
Facility Name
Ospedale S. Antonio Abate
City
Gallarate Varese
ZIP/Postal Code
21013
Country
Italy
Facility Name
Ospedale Di Gela
City
Gela - CL
ZIP/Postal Code
930123
Country
Italy
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale San Martino
City
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Presidio Ospedaliero-Gorizia
City
Gorizia
ZIP/Postal Code
34170
Country
Italy
Facility Name
Ospedale Misericordia USL 9
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Facility Name
INI Grottaferrata
City
Grottaferrata
ZIP/Postal Code
00046
Country
Italy
Facility Name
Ospedale Nuovo
City
Imola
ZIP/Postal Code
40026
Country
Italy
Facility Name
Ospedali Vecchi
City
Imola
ZIP/Postal Code
40026
Country
Italy
Facility Name
Ospedale Civile di Ivrea
City
Ivrea
ZIP/Postal Code
10015
Country
Italy
Facility Name
Ospendale S. Andrea EST
City
La Spezia
ZIP/Postal Code
19100
Country
Italy
Facility Name
Ospedale Civile Lanciano
City
Lanciano
ZIP/Postal Code
66034
Country
Italy
Facility Name
Ospedale Santa Maria Goretti
City
Latina
ZIP/Postal Code
04100
Country
Italy
Facility Name
Ospedale Alessandro Manzoni
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Ospedale Civile di Legnano
City
Legnano
ZIP/Postal Code
20025
Country
Italy
Facility Name
Presidio Ospedaliero di Livorno
City
Livorno
ZIP/Postal Code
57100
Country
Italy
Facility Name
Carlo Poma Hospital
City
Mantova
ZIP/Postal Code
46100
Country
Italy
Facility Name
Ospedale Papardo
City
Messina
ZIP/Postal Code
98100
Country
Italy
Facility Name
Policlinico Messina
City
Messina
ZIP/Postal Code
98123
Country
Italy
Facility Name
University of Milan
City
Milan
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale San Giuseppe
City
Milan
ZIP/Postal Code
20123
Country
Italy
Facility Name
Istituto Scientifico H. San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
European Institute of Oncology
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Ospedale Fatebene Fratelli
City
Milan
ZIP/Postal Code
20152
Country
Italy
Facility Name
Ospedale San Carlo Borromeo
City
Milan
ZIP/Postal Code
20153
Country
Italy
Facility Name
Ospedale Luigi Sacco
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
Azienda Ospedaliera - Universitaria di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Sant Agostino - Estenes Institutes
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Policlinico Monserrato
City
Monserrato - CA
ZIP/Postal Code
09042
Country
Italy
Facility Name
Clinica Urologica II
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Ospedale San Gerardo
City
Monza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Azienda Ospedaliera "A. Cardarelli"
City
Naples
ZIP/Postal Code
80127
Country
Italy
Facility Name
Federico II University Medical School
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Tumori/Fondazione Pascale
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Civile Negrar
City
Negrar
ZIP/Postal Code
37024
Country
Italy
Facility Name
Azienda Ospedaliera Maggiore Della Carita
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Azienda Ospedale S. Luigi at University of Torino
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Casa di Cura Noto Pasqualino
City
Palermo
ZIP/Postal Code
90100
Country
Italy
Facility Name
Ospedale Oncology M. Ascoli
City
Palermo
ZIP/Postal Code
90100
Country
Italy
Facility Name
Ospedale La Maddalena - Palermo
City
Palermo
Country
Italy
Facility Name
Azienda Ospedaliera Di Parma
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Fondazione I.R.C.C.S. Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Universita Degli Studi
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedale - d "S. Salvatore"
City
Pesaro
ZIP/Postal Code
61100
Country
Italy
Facility Name
Ospedale Spiritito Santo
City
Pescara
ZIP/Postal Code
65100
Country
Italy
Facility Name
Ospedale Santa Corona
City
Pietra Ligure -SV
ZIP/Postal Code
17029
Country
Italy
Facility Name
Ospedale Santa Chiara Pisa
City
Pisa
ZIP/Postal Code
I-56126
Country
Italy
Facility Name
Ospedale Pistoia
City
Pistoia
ZIP/Postal Code
51100
Country
Italy
Facility Name
Azienda Ospedaliera "Santa Maria Degli Angeli"
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Azienda U.S.L. Cesena
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Ospedale Carlo Forlanini
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Ospedale Di Rivoli
City
Rivoli
ZIP/Postal Code
10098
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea
City
Rome
ZIP/Postal Code
00100
Country
Italy
Facility Name
Ospedale C.T.O. Roma
City
Rome
ZIP/Postal Code
00100
Country
Italy
Facility Name
Ospedale Sant' Eugenio
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Ospedaliera S. Camillo-Forlanini
City
Rome
ZIP/Postal Code
00151
Country
Italy
Facility Name
Azienda Policlinico Umberto Primo
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Istituto Regina Elena
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Fatebenefratelli, Isola Tiberina Hospital
City
Rome
ZIP/Postal Code
00186
Country
Italy
Facility Name
Ospedale San Pietro Fatebenefratelli
City
Rome
ZIP/Postal Code
00189
Country
Italy
Facility Name
Ospedale Civile di Rovigo
City
Rovigo
ZIP/Postal Code
45100
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Ospedale Saluzzo
City
Saluzzo - CN
ZIP/Postal Code
12037
Country
Italy
Facility Name
Ospedale San Daniele del Friuli
City
San Daniele del Friuli
ZIP/Postal Code
33038
Country
Italy
Facility Name
Ospedale Casa Sollievo della Sofferenza
City
San Giovanni - Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
ASL NO. 1 Imperiese
City
San Remo
ZIP/Postal Code
18038
Country
Italy
Facility Name
Ospedale Civile G Borea
City
San Remo
ZIP/Postal Code
18038
Country
Italy
Facility Name
Ospedale Civile Di San Vito Al Tagliamento
City
San Vito Al Talgliamento
Country
Italy
Facility Name
Az. Ospedale Villa Scassi
City
Sandpierdarena
ZIP/Postal Code
16100
Country
Italy
Facility Name
Istituto Clinica Medica
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Ospedale Civile ASL 1
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Ospedale SS Trinita
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Policlinico Sassari
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Ospedali Savigliano
City
Savigliano - CN
ZIP/Postal Code
12038
Country
Italy
Facility Name
Ospedale S. Paolo Valloria
City
Savona
ZIP/Postal Code
17100
Country
Italy
Facility Name
Ospedale Civile Sestri Levante
City
Sestri Levante - GE
ZIP/Postal Code
16039
Country
Italy
Facility Name
Universita di Siena
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Ospedale Umberto 1
City
Siracusa
ZIP/Postal Code
95100
Country
Italy
Facility Name
Osepdale Civile
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Facility Name
Ospedale SS Trinita
City
Sora
ZIP/Postal Code
03039
Country
Italy
Facility Name
SS Annunziata
City
Sulmona
ZIP/Postal Code
67039
Country
Italy
Facility Name
Ospedale S. Vincenzo
City
Taormina
ZIP/Postal Code
98039
Country
Italy
Facility Name
Ospedale Civile Teramo
City
Teramo
ZIP/Postal Code
64100
Country
Italy
Facility Name
Ospedale Generale Prov. Boldrini
City
Thiene
ZIP/Postal Code
36016
Country
Italy
Facility Name
Ospedale Civile
City
Tolmezzo Gemona F.
ZIP/Postal Code
33013
Country
Italy
Facility Name
Ospedale Civile Trapani
City
Trapani
ZIP/Postal Code
91100
Country
Italy
Facility Name
Ospedale Di Trento
City
Trento
ZIP/Postal Code
38100
Country
Italy
Facility Name
Primario U.O. di Oncologia Medica
City
Trento
ZIP/Postal Code
38100
Country
Italy
Facility Name
Ospedale Cattinara
City
Trieste
Country
Italy
Facility Name
Ospedale Amedeo Savoia
City
Turin
ZIP/Postal Code
10100
Country
Italy
Facility Name
Ospedale Martini
City
Turin
ZIP/Postal Code
10100
Country
Italy
Facility Name
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale Gradenigo
City
Turin
ZIP/Postal Code
10153
Country
Italy
Facility Name
Ospedale Cottolengo
City
Turin
Country
Italy
Facility Name
Ospedale Giovanni Bosco
City
Turin
Country
Italy
Facility Name
Ospedale S. Giovanni Vecchio
City
Turin
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Ospedale Civile ULSS 12
City
Venezia
ZIP/Postal Code
30100
Country
Italy
Facility Name
Ospedale Civile Verbania
City
Verbania
ZIP/Postal Code
28900
Country
Italy
Facility Name
Ospedal San Andrea
City
Vercelli
ZIP/Postal Code
13100
Country
Italy
Facility Name
Policlinico Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Policlinico G. B. Rossi - Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Ospedale San Bortolo
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Presidio Ospedaliero Belcolle
City
Viterbo
ZIP/Postal Code
I-01100
Country
Italy

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result

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

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