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Bladder CancerPhase 3NCT00054626

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

A Phase 3 study testing cisplatin, gemcitabine hydrochloride and adjuvant therapy in people with Bladder Cancer, run by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy at 151 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Bladder Cancer
What is being tested?
cisplatin, gemcitabine hydrochloride and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
700 participants
Where
151 sitesItaly
Study dates
Sep 2001to Jun 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

151 sites in 1 country.

151 sites in 1 country

Italy151 sites

  • Ospedale Civile Via Caronia

    Acireale - CT, 95024

  • Ospedale San Lazzaro

    Alba, 12051

  • Ospedale S. Giuseppe

    Albano Laziale, 00041

  • Ospedale SS. Biagio e Arrigo

    Alessandria, 15100

  • Ospedale Civile Alessandria

    Alessandria, I-15100

  • Presidio Ospedale

    Anagni, 03012

  • Ospedale Torrette University Ancona

    Ancona, 60020

  • Ospedale Generale Umberto 1

    Ancona, 60100

  • Istituto Nazionale Riposo e Cura Anziani Istituto

    Ancona - AN, 60100

  • Ospedale S. Donato

    Arezzo, 52100

  • Ospedale Civile di Asti

    Asti, 14100

  • S.G. Moscati Hospital

    Avellino, 83100

  • Ospedale Civile Avezzano

    Avezzano, 67051

  • Centro di Riferimento Oncologico - Aviano

    Aviano, 33081

  • Universita Degli Studi di Bari

    Bari, 70124

  • Istituto Di Ricovero E Cura A Carattere Scientifico

    Bari, 70126

  • Ospedale di Venere - Carbonara

    Bari-Carbonara, 70100

  • Ospedale S. Martino

    Belluno, 32100

  • Ospedali Riuniti di Bergamo

    Bergamo, 24100

  • Ospedale degli Infermi - ASL 12

    Biella, 13900

  • Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi

    Bologna, 40138

  • Azienda Sanitaria di Bolzano

    Bolzano, 39100

  • Ospedale S. Trinita

    Borgomanero, 28021

  • Spedali Civili di Brescia

    Brescia, 25124

  • Ospedale di Busto Arsizio

    Busto Arsizio, 21052

  • Ospedale SS Trinita

    Cagliari, 09100

  • Ospedale Caltanissetta

    Caltanissetta, 93100

  • Ospedale Civile Camposanpiero

    Camposanpiero, 35012

  • Istituto per la Ricerca e Cura del Cancro

    Candiolo, 10060

  • Civic Hospital of Carrara

    Carrara, I-54033

  • Ospedale S. Spirito

    Casale Monferrato, 15033

  • Ospedale S. Leonardo

    Castellammare Di Stabia - NA, 80053

  • Ospedale Cannnizzaro

    Catania, 95100

  • Ospedale S. Luigi

    Catania, 95100

  • Ospedale Regionale A. Pugliese

    Catanzaro, 88100

  • Ospedale SS Annunziata

    Chieti, 66100

  • Universita G.D'Annunzio Di Chieti

    Chieti, 66100

  • Ospedale Di Cirie

    Cirié, 10073

  • Ospedale Sant Anna

    Como, 22100

  • Ospedale Maggiore Crema

    Crema, 26013

  • Ospedale Civile S. Croce

    Fano, 61032

  • Ospedale Fidenza

    Fidenza, 43036

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

    Florence, I-50011

  • Morgagni-Pierantoni Ospedale

    Forlì, 47100

  • Ospedale S. Sebastiano

    Frascati - RM, 00044

  • Ospedale Umberto I

    Frosinone, 03100

  • Ospedale S. Antonio Abate

    Gallarate Varese, 21013

  • Ospedale Di Gela

    Gela - CL, 930123

  • Istituto Nazionale per la Ricerca sul Cancro

    Genoa, 16132

  • Ospedale San Martino

    Genoa, 16132

  • Presidio Ospedaliero-Gorizia

    Gorizia, 34170

  • Ospedale Misericordia USL 9

    Grosseto, 58100

  • INI Grottaferrata

    Grottaferrata, 00046

  • Ospedale Nuovo

    Imola, 40026

  • Ospedali Vecchi

    Imola, 40026

  • Ospedale Civile di Ivrea

    Ivrea, 10015

  • Ospendale S. Andrea EST

    La Spezia, 19100

  • Ospedale Civile Lanciano

    Lanciano, 66034

  • Ospedale Santa Maria Goretti

    Latina, 04100

  • Ospedale Alessandro Manzoni

    Lecco, 23900

  • Ospedale Civile di Legnano

    Legnano, 20025

  • Presidio Ospedaliero di Livorno

    Livorno, 57100

  • Carlo Poma Hospital

    Mantua, 46100

  • Ospedale Papardo

    Messina, 98100

  • Policlinico Messina

    Messina, 98123

  • University of Milan

    Milan, 20122

  • Ospedale San Giuseppe

    Milan, 20123

  • Istituto Scientifico H. San Raffaele

    Milan, 20132

  • European Institute of Oncology

    Milan, 20141

  • Ospedale Fatebene Fratelli

    Milan, 20152

  • Ospedale San Carlo Borromeo

    Milan, 20153

  • Ospedale Luigi Sacco

    Milan, 20157

  • Azienda Ospedaliera - Universitaria di Modena

    Modena, 41100

  • Sant Agostino - Estenes Institutes

    Modena, 41100

  • Policlinico Monserrato

    Monserrato - CA, 09042

  • Clinica Urologica II

    Monza, 20052

  • Ospedale San Gerardo

    Monza, 20052

  • Azienda Ospedaliera "A. Cardarelli"

    Naples, 80127

  • Federico II University Medical School

    Naples, 80131

  • Istituto Tumori/Fondazione Pascale

    Naples, 80131

  • Ospedale Civile Negrar

    Negrar, 37024

  • Azienda Ospedaliera Maggiore Della Carita

    Novara, 28100

  • Azienda Ospedale S. Luigi at University of Torino

    Orbassano, 10043

  • Casa di Cura Noto Pasqualino

    Palermo, 90100

  • Ospedale Oncology M. Ascoli

    Palermo, 90100

  • Ospedale La Maddalena - Palermo

    Palermo

  • Azienda Ospedaliera Di Parma

    Parma, 43100

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

    Pavia, 27100

  • Universita Degli Studi

    Pavia, 27100

  • Azienda Ospedale - d "S. Salvatore"

    Pesaro, 61100

  • Ospedale Spiritito Santo

    Pescara, 65100

  • Ospedale Santa Corona

    Pietra Ligure -SV, 17029

  • Ospedale Santa Chiara Pisa

    Pisa, I-56126

  • Ospedale Pistoia

    Pistoia, 51100

  • Azienda Ospedaliera "Santa Maria Degli Angeli"

    Pordenone, 33170

  • Azienda U.S.L. Cesena

    Potenza, 85100

  • Ospedale Carlo Forlanini

    Potenza, 85100

  • Ospedale Di Rivoli

    Rivoli, 10098

  • Azienda Ospedaliera Sant'Andrea

    Rome, 00100

  • Ospedale C.T.O. Roma

    Rome, 00100

  • Ospedale Sant' Eugenio

    Rome, 00144

  • Azienda Ospedaliera S. Camillo-Forlanini

    Rome, 00151

  • Azienda Policlinico Umberto Primo

    Rome, 00161

  • Istituto Regina Elena

    Rome, 00161

  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

    Rome, 00168

  • Fatebenefratelli, Isola Tiberina Hospital

    Rome, 00186

  • Ospedale San Pietro Fatebenefratelli

    Rome, 00189

  • Ospedale Civile di Rovigo

    Rovigo, 45100

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • Ospedale Saluzzo

    Saluzzo - CN, 12037

  • Ospedale San Daniele del Friuli

    San Daniele del Friuli, 33038

  • Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • Ospedale Civile Di San Vito Al Tagliamento

    San Vito Al Talgliamento

  • Az. Ospedale Villa Scassi

    Sandpierdarena, 16100

  • ASL NO. 1 Imperiese

    Sanremo, 18038

  • Ospedale Civile G Borea

    Sanremo, 18038

  • Istituto Clinica Medica

    Sassari, 07100

  • Ospedale Civile ASL 1

    Sassari, 07100

  • Ospedale SS Trinita

    Sassari, 07100

  • Policlinico Sassari

    Sassari, 07100

  • Ospedali Savigliano

    Savigliano - CN, 12038

  • Ospedale S. Paolo Valloria

    Savona, 17100

  • Ospedale Civile Sestri Levante

    Sestri Levante - GE, 16039

  • Universita di Siena

    Siena, 53100

  • Osepdale Civile

    Sondrio, 23100

  • Ospedale SS Trinita

    Sora, 03039

  • SS Annunziata

    Sulmona, 67039

  • Ospedale Umberto 1

    Syracuse, 95100

  • Ospedale S. Vincenzo

    Taormina, 98039

  • Ospedale Civile Teramo

    Teramo, 64100

  • Ospedale Generale Prov. Boldrini

    Thiene, 36016

  • Ospedale Civile

    Tolmezzo Gemona F., 33013

  • Ospedale Civile Trapani

    Trapani, 91100

  • Ospedale Di Trento

    Trento, 38100

  • Primario U.O. di Oncologia Medica

    Trento, 38100

  • Ospedale Cattinara

    Trieste

  • Ospedale Amedeo Savoia

    Turin, 10100

  • Ospedale Martini

    Turin, 10100

  • Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

    Turin, 10126

  • Ospedale Gradenigo

    Turin, 10153

  • Ospedale Cottolengo

    Turin

  • Ospedale Giovanni Bosco

    Turin

  • Ospedale S. Giovanni Vecchio

    Turin

  • Azienda Ospedaliera Santa Maria della Misericordia

    Udine, 33100

  • Ospedale Civile ULSS 12

    Venezia, 30100

  • Ospedale Civile Verbania

    Verbania, 28900

  • Ospedal San Andrea

    Vercelli, 13100

  • Policlinico Borgo Roma

    Verona, 37134

  • Policlinico G. B. Rossi - Borgo Roma

    Verona, 37134

  • Ospedale San Bortolo

    Vicenza, 36100

  • Presidio Ospedaliero Belcolle

    Viterbo, I-01100

Other trials in Italy

About this study

Official title: Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer

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.

Read the 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.

Conditions
Bladder Cancer
Keywords
stage II bladder cancer, stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival at 5 years

Secondary outcomes (6)

  1. Disease-free survival at 5 years

  2. Local disease-free survival at 5 years

  3. Distant disease-free survival at 5 years

  4. Toxicity by WHO system grading after each course

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

  6. Dose intensity at the end of the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2003 (estimated)
  2. Study startSep 2001
  3. Primary completionJun 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054626
Sponsor's protocol ID
CDR0000258426
Other IDs
ITNRC-CU02.00447ST/97, NCI-V02-1715
Status last verified
Nov 2008
First submitted
5 Feb 2003
Last updated
18 Dec 2013
Results posted
No

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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, gemcitabine hydrochloride and adjuvant therapy in people with Bladder Cancer, run by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy at 151 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival at 5 years. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00054626, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.

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