Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00054626
First received: February 5, 2003
Last updated: February 6, 2009
Last verified: November 2008
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Overall survival at 5 years [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Disease-free survival at 5 years [ Designated as safety issue: No ]
- Local disease-free survival at 5 years [ Designated as safety issue: No ]
- Distant disease-free survival at 5 years [ Designated as safety issue: No ]
- Toxicity by WHO system grading after each course [ Designated as safety issue: Yes ]
- Quality of life after each course and every 6 months during follow-up [ Designated as safety issue: No ]
- Dose intensity at the end of the treatment [ Designated as safety issue: No ]
| Estimated Enrollment: | 700 |
| Study Start Date: | September 2001 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054626
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| Italy | |
| Ospedale Civile Via Caronia | |
| Acireale - CT, Italy, 95024 | |
| Ospedale San Lazzaro | |
| Alba, Italy, 12051 | |
| Ospedale S. Giuseppe | |
| Albano, Italy, 00041 | |
| Ospedale SS. Biagio e Arrigo | |
| Alessandria, Italy, 15100 | |
| Ospedale Civile Alessandria | |
| Alessandria, Italy, I-15100 | |
| Presidio Ospedale | |
| Anagni, Italy, 03012 | |
| Ospedale Torrette University Ancona | |
| Ancona, Italy, 60020 | |
| Ospedale Generale Umberto 1 | |
| Ancona, Italy, 60100 | |
| Istituto Nazionale Riposo e Cura Anziani Istituto | |
| Ancona - AN, Italy, 60100 | |
| Ospedale S. Donato | |
| Arezzo, Italy, 52100 | |
| Ospedale Civile di Asti | |
| Asti, Italy, 14100 | |
| S.G. Moscati Hospital | |
| Avellino, Italy, 83100 | |
| Ospedale Civile Avezzano | |
| Avezzano, Italy, 67051 | |
| Centro di Riferimento Oncologico - Aviano | |
| Aviano, Italy, 33081 | |
| Istituto Di Ricovero E Cura A Carattere Scientifico | |
| Bari, Italy, 70126 | |
| Universita Degli Studi di Bari | |
| Bari, Italy, 70124 | |
| Ospedale di Venere - Carbonara | |
| Bari-Carbonara, Italy, 70100 | |
| Ospedale S. Martino | |
| Belluno, Italy, 32100 | |
| Ospedali Riuniti di Bergamo | |
| Bergamo, Italy, 24100 | |
| Ospedale degli Infermi - ASL 12 | |
| Biella, Italy, 13900 | |
| Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi | |
| Bologna, Italy, 40138 | |
| Azienda Sanitaria di Bolzano | |
| Bolzano, Italy, 39100 | |
| Ospedale S. Trinita | |
| Borgomanero, Italy, 28021 | |
| Spedali Civili di Brescia | |
| Brescia, Italy, 25124 | |
| Ospedale di Busto Arsizio | |
| Busto Arsizio, Italy, 21052 | |
| Ospedale SS Trinita | |
| Cagliari, Italy, 09100 | |
| Ospedale Caltanissetta | |
| Caltanissetta, Italy, 93100 | |
| Ospedale Civile Camposanpiero | |
| Camposanpiero, Italy, 35012 | |
| Istituto per la Ricerca e Cura del Cancro | |
| Candiolo, Italy, 10060 | |
| Civic Hospital of Carrara | |
| Carrara, Italy, I-54033 | |
| Ospedale S. Spirito | |
| Casale Monferrato, Italy, 15033 | |
| Ospedale S. Leonardo | |
| Castellammare di Stabia - NA, Italy, 80053 | |
| Ospedale S. Luigi | |
| Catania, Italy, 95100 | |
| Ospedale Cannnizzaro | |
| Catania, Italy, 95100 | |
| Ospedale Regionale A. Pugliese | |
| Catanzaro, Italy, 88100 | |
| Ospedale SS Annunziata | |
| Chieti, Italy, 66100 | |
| Universita G.D'Annunzio Di Chieti | |
| Chieti, Italy, 66100 | |
| Ospedale Di Cirie | |
| Cirie, Italy, 10073 | |
| Ospedale Sant Anna | |
| Como, Italy, 22100 | |
| Ospedale Maggiore Crema | |
| Crema, Italy, 26013 | |
| Ospedale Civile S. Croce | |
| Fano, Italy, 61032 | |
| Ospedale Fidenza | |
| Fidenza, Italy, 43036 | |
| Ospendale S.M. Annunziata-A.S.DI Florence | |
| Florence, Italy, I-50011 | |
| Morgagni-Pierantoni Ospedale | |
| Forli, Italy, 47100 | |
| Ospedale S. Sebastiano | |
| Frascati - RM, Italy, 00044 | |
| Ospedale Umberto I | |
| Frosinone, Italy, 03100 | |
| Ospedale S. Antonio Abate | |
| Gallarate Varese, Italy, 21013 | |
| Ospedale Di Gela | |
| Gela - CL, Italy, 930123 | |
| Ospedale San Martino | |
| Genoa, Italy, 16132 | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa, Italy, 16132 | |
| Presidio Ospedaliero-Gorizia | |
| Gorizia, Italy, 34170 | |
| Ospedale Misericordia USL 9 | |
| Grosseto, Italy, 58100 | |
| INI Grottaferrata | |
| Grottaferrata, Italy, 00046 | |
| Ospedali Vecchi | |
| Imola, Italy, 40026 | |
| Ospedale Nuovo | |
| Imola, Italy, 40026 | |
| Ospedale Civile di Ivrea | |
| Ivrea, Italy, 10015 | |
| Ospendale S. Andrea EST | |
| La Spezia, Italy, 19100 | |
| Ospedale Civile Lanciano | |
| Lanciano, Italy, 66034 | |
| Ospedale Santa Maria Goretti | |
| Latina, Italy, 04100 | |
| Ospedale Alessandro Manzoni | |
| Lecco, Italy, 23900 | |
| Ospedale Civile di Legnano | |
| Legnano, Italy, 20025 | |
| Presidio Ospedaliero di Livorno | |
| Livorno, Italy, 57100 | |
| Carlo Poma Hospital | |
| Mantova, Italy, 46100 | |
| Policlinico Messina | |
| Messina, Italy, 98123 | |
| Ospedale Papardo | |
| Messina, Italy, 98100 | |
| European Institute of Oncology | |
| Milan, Italy, 20141 | |
| Ospedale Fatebene Fratelli | |
| Milan, Italy, 20152 | |
| Istituto Scientifico H. San Raffaele | |
| Milan, Italy, 20132 | |
| University of Milan | |
| Milan, Italy, 20122 | |
| Ospedale San Giuseppe | |
| Milan, Italy, 20123 | |
| Ospedale Luigi Sacco | |
| Milan, Italy, 20157 | |
| Ospedale San Carlo Borromeo | |
| Milan, Italy, 20153 | |
| Azienda Ospedaliera - Universitaria di Modena | |
| Modena, Italy, 41100 | |
| Sant Agostino - Estenes Institutes | |
| Modena, Italy, 41100 | |
| Policlinico Monserrato | |
| Monserrato - CA, Italy, 09042 | |
| Ospedale San Gerardo | |
| Monza, Italy, 20052 | |
| Clinica Urologica II | |
| Monza, Italy, 20052 | |
| Azienda Ospedaliera "A. Cardarelli" | |
| Naples, Italy, 80127 | |
| Istituto Tumori/Fondazione Pascale | |
| Naples, Italy, 80131 | |
| Federico II University Medical School | |
| Naples, Italy, 80131 | |
| Ospedale Civile Negrar | |
| Negrar, Italy, 37024 | |
| Azienda Ospedaliera Maggiore Della Carita | |
| Novara, Italy, 28100 | |
| Azienda Ospedale S. Luigi at University of Torino | |
| Orbassano, Italy, 10043 | |
| Ospedale La Maddalena - Palermo | |
| Palermo, Italy | |
| Casa di Cura Noto Pasqualino | |
| Palermo, Italy, 90100 | |
| Ospedale Oncology M. Ascoli | |
| Palermo, Italy, 90100 | |
| Azienda Ospedaliera Di Parma | |
| Parma, Italy, 43100 | |
| Fondazione I.R.C.C.S. Policlinico San Matteo | |
| Pavia, Italy, 27100 | |
| Universita Degli Studi | |
| Pavia, Italy, 27100 | |
| Azienda Ospedale - d "S. Salvatore" | |
| Pesaro, Italy, 61100 | |
| Ospedale Spiritito Santo | |
| Pescara, Italy, 65100 | |
| Ospedale Santa Corona | |
| Pietra Ligure -SV, Italy, 17029 | |
| Ospedale Santa Chiara Pisa | |
| Pisa, Italy, I-56126 | |
| Ospedale Pistoia | |
| Pistoia, Italy, 51100 | |
| Azienda Ospedaliera "Santa Maria Degli Angeli" | |
| Pordenone, Italy, 33170 | |
| Ospedale Carlo Forlanini | |
| Potenza, Italy, 85100 | |
| Azienda U.S.L. Cesena | |
| Potenza, Italy, 85100 | |
| Ospedale Di Rivoli | |
| Rivoli, Italy, 10098 | |
| Ospedale C.T.O. Roma | |
| Rome, Italy, 00100 | |
| Azienda Ospedaliera Sant'Andrea | |
| Rome, Italy, 00100 | |
| Azienda Policlinico Umberto Primo | |
| Rome, Italy, 00161 | |
| Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | |
| Rome, Italy, 00168 | |
| Ospedale Sant' Eugenio | |
| Rome, Italy, 00144 | |
| Istituto Regina Elena | |
| Rome, Italy, 00161 | |
| Fatebenefratelli, Isola Tiberina Hospital | |
| Rome, Italy, 00186 | |
| Azienda Ospedaliera S. Camillo-Forlanini | |
| Rome, Italy, 00151 | |
| Ospedale San Pietro Fatebenefratelli | |
| Rome, Italy, 00189 | |
| Ospedale Civile di Rovigo | |
| Rovigo, Italy, 45100 | |
| Istituto Clinico Humanitas | |
| Rozzano, Italy, 20089 | |
| Ospedale Saluzzo | |
| Saluzzo - CN, Italy, 12037 | |
| Ospedale San Daniele del Friuli | |
| San Daniele del Friuli, Italy, 33038 | |
| Ospedale Casa Sollievo della Sofferenza | |
| San Giovanni - Rotondo, Italy, 71013 | |
| ASL NO. 1 Imperiese | |
| San Remo, Italy, 18038 | |
| Ospedale Civile G Borea | |
| San Remo, Italy, 18038 | |
| Ospedale Civile Di San Vito Al Tagliamento | |
| San Vito Al Talgliamento, Italy | |
| Az. Ospedale Villa Scassi | |
| Sandpierdarena, Italy, 16100 | |
| Istituto Clinica Medica | |
| Sassari, Italy, 07100 | |
| Ospedale Civile ASL 1 | |
| Sassari, Italy, 07100 | |
| Policlinico Sassari | |
| Sassari, Italy, 07100 | |
| Ospedale SS Trinita | |
| Sassari, Italy, 07100 | |
| Ospedali Savigliano | |
| Savigliano - CN, Italy, 12038 | |
| Ospedale S. Paolo Valloria | |
| Savona, Italy, 17100 | |
| Ospedale Civile Sestri Levante | |
| Sestri Levante - GE, Italy, 16039 | |
| Universita di Siena | |
| Siena, Italy, 53100 | |
| Ospedale Umberto 1 | |
| Siracusa, Italy, 95100 | |
| Osepdale Civile | |
| Sondrio, Italy, 23100 | |
| Ospedale SS Trinita | |
| Sora, Italy, 03039 | |
| SS Annunziata | |
| Sulmona, Italy, 67039 | |
| Ospedale S. Vincenzo | |
| Taormina, Italy, 98039 | |
| Ospedale Civile Teramo | |
| Teramo, Italy, 64100 | |
| Ospedale Generale Prov. Boldrini | |
| Thiene, Italy, 36016 | |
| Ospedale Civile | |
| Tolmezzo Gemona F., Italy, 33013 | |
| Ospedale Civile Trapani | |
| Trapani, Italy, 91100 | |
| Ospedale Di Trento | |
| Trento, Italy, 38100 | |
| Primario U.O. di Oncologia Medica | |
| Trento, Italy, 38100 | |
| Ospedale Cattinara | |
| Trieste, Italy | |
| Ospedale Giovanni Bosco | |
| Turin, Italy | |
| Ospedale Amedeo Savoia | |
| Turin, Italy, 10100 | |
| Ospedale S. Giovanni Vecchio | |
| Turin, Italy | |
| Ospedale Gradenigo | |
| Turin, Italy, 10153 | |
| Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | |
| Turin, Italy, 10126 | |
| Ospedale Martini | |
| Turin, Italy, 10100 | |
| Ospedale Cottolengo | |
| Turin, Italy | |
| Azienda Ospedaliera Santa Maria della Misericordia | |
| Udine, Italy, 33100 | |
| Ospedale Civile ULSS 12 | |
| Venezia, Italy, 30100 | |
| Ospedale Civile Verbania | |
| Verbania, Italy, 28900 | |
| Ospedal San Andrea | |
| Vercelli, Italy, 13100 | |
| Policlinico G. B. Rossi - Borgo Roma | |
| Verona, Italy, 37134 | |
| Policlinico Borgo Roma | |
| Verona, Italy, 37134 | |
| Ospedale San Bortolo | |
| Vicenza, Italy, 36100 | |
| Presidio Ospedaliero Belcolle | |
| Viterbo, Italy, I-01100 | |
Sponsors and Collaborators
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Investigators
| Study Chair: | Camillo F. Pollera, MD | Presidio Ospedaliero Belcolle |
More Information
Publications:
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.
| ClinicalTrials.gov Identifier: | NCT00054626 History of Changes |
| Other Study ID Numbers: | CDR0000258426, ITNRC-CU02.00447ST/97, NCI-V02-1715 |
| Study First Received: | February 5, 2003 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II bladder cancer stage III bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Adjuvants, Immunologic Gemcitabine Cisplatin Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 16, 2013