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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of Immediate Versus Deferred Adjuvant Chemotherapy After Radical Cystectomy in Patients With Stage III or IV Transitional Cell Carcinoma of the Bladder Urothelium

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active Not specified NCI, Other EORTC-30994 ACOSOG-EORTC-30994, CAN-NCIC-EORTC-30994, FNCLCC-GETUG-EORTC-30994, JUG-EORTC-30994, NORDIC-EORTC-30994, SEUG-EORTC-30994, SWOG-EORTC-30994, UKCCCR-EORTC-30994, NCRI-BLADDER-EORTC-30994, NCT00028756

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known if adjuvant chemotherapy is more effective when given immediately after radical cystectomy (surgery to remove the bladder) or when the cancer returns.

Randomized phase III trial to compare the effectiveness of immediate adjuvant chemotherapy with that of adjuvant chemotherapy given when the cancer returns in treating patients who have undergone a radical cystectomy for stage III or stage IV transitional cell carcinoma of the bladder urothelium.

Eligibility:

Eligibility criteria include the following:

• No more than 3 months since surgery to remove the bladder and lymph nodes near the tumor
• No previous systemic chemotherapy
• No previous radiation therapy to the bladder
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Beginning within 3 months after surgery, patients in group one will receive one of three different combination chemotherapy regimens for a total of four courses. Patients in group two will receive no treatment until the cancer returns. They will then receive treatment as in group one for six courses. Patients will be evaluated every 3 months for 1 year, every 6 months for 5 years, and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Cora Sternberg, MD, FACP, Study coordinator		Ph: 39-06-6641-8008 Email: cstern@mclink.it

Groupe D'Etude des Tumeurs Uro-Genitales

Christine Theodore, MD, Protocol chair		Ph: 33-1-4625-2149 Email: c.theodore@hopital-foch.org

Nordic Urothelial Cancer Group

Sten Nilsson, MD, Protocol chair		Ph: 46-8-517-717-80

NCIC-Clinical Trials Group

Armen Aprikian, MD, Protocol chair		Ph: 514-934-8295 Email: armen.aprikian@mnhc.mcgill.ca

National Cancer Research Institute

Michael Leahy, MBChB, FRACP, FRCP, FRC Path, Protocol chair		Ph: 61-8-9431-2886

American College of Surgeons Oncology Group

Ian Tannock, MD, PhD, Protocol chair		Ph: 416-946-2245 Email: ian.tannock@uhn.on.ca

Austria
	Vienna
	Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
		Contact Person	Ph:  43-1-601-9152
Belgium
	Aalst
	Onze Lieve Vrouw Ziekenhuis Aalst
		Contact Person	Ph:  32-53-78-5353
	Brussels
	Cliniques Universitaires Saint-Luc
		Contact Person	Ph:  32-2-764-1111
	Institut Jules Bordet
		Contact Person	Ph:  32-2-541-3111
	Ghent
	Universitair Ziekenhuis Gent
		Contact Person	Ph:  32-92-240-2011
	Kortrijk
	Cazk Groeninghe - Campus Maria's Voorzienigheid
		Contact Person	Ph:  32-562-34211
	Leuven
	U.Z. Gasthuisberg
		Contact Person	Ph:  32-16-33-2211
	Liege
	CHU Liege - Domaine Universitaire du Sart Tilman
		Contact Person	Ph:  32-42-366-7111
Canada
Alberta
	Calgary
	Tom Baker Cancer Centre - Calgary
		Contact Person	Ph:  403-270-1700
	Edmonton
	Cross Cancer Institute at University of Alberta
		Contact Person	Ph:  780-432-8771
British Columbia
	Kelowna
	British Columbia Cancer Agency - Centre for the Southern Interior
		Contact Person	Ph:  250-712-3900
	Vancouver
	British Columbia Cancer Agency - Vancouver Cancer Centre
		Contact Person	Ph:  604-877-6000
	Victoria
	British Columbia Cancer Agency - Vancouver Island Centre
		Contact Person	Ph:  250-519-5500
Manitoba
	Winnipeg
	CancerCare Manitoba
		Contact Person	Ph:  204-787-2241
Nova Scotia
	Halifax
	Nova Scotia Cancer Centre
		Contact Person	Ph:  902-473-6000
Ontario
	Hamilton
	Margaret and Charles Juravinski Cancer Centre
		Contact Person	Ph:  905-387-9495
	Kingston
	Cancer Centre of Southeastern Ontario at Kingston General Hospital
		Contact Person	Ph:  613-544-2630
	London
	London Regional Cancer Program at London Health Sciences Centre
		Contact Person	Ph:  519-685-8600
	Ottawa
	Ottawa Hospital Regional Cancer Centre - General Campus
		Contact Person	Ph:  613-725-6300
	St. Catharines
	St. Catharines General Hospital at Niagara Health System
		Contact Person	Ph:  905-682-6451
	Toronto
	Edmond Odette Cancer Centre at Sunnybrook
		Contact Person	Ph:  416-480-5000
	Princess Margaret Hospital
		Contact Person	Ph:  416-946-2000
Quebec
	Montreal
	Hopital Notre-Dame du CHUM
		Contact Person	Ph:  514-890-8000
	McGill Cancer Centre at McGill University
		Contact Person	Ph:  514-398-1444
	Montreal General Hospital
		Armen Aprikian, MD	Ph:  514-934-8295
			Email: armen.aprikian@mnhc.mcgill.ca
Denmark
	Aarhus
	Aarhus Universitetshospital - Aarhus Sygehus
		Contact Person	Ph:  45-89-49-3333
	Copenhagen
	Copenhagen County Herlev University Hospital
		Contact Person	Ph:  45-44-88-3499
	Rigshospitalet - Copenhagen University Hospital
		Cotnact Person	Ph:  45-3545-3545
France
	Angers
	Centre Paul Papin
		Contact Person	Ph:  33-2-4135-2700
	Bordeaux
	Hopital Saint Andre
		Contact Person	Ph:  33-56-79-58-08
	Institut Bergonie
		Contact Person	Ph:  33-5-5633-3333
	Caen
	Centre Regional Francois Baclesse
		Contact Person	Ph:  33-2-3145-5000
	Creteil
	Centre Hospitalier Universitaire Henri Mondor
		Contact Person	Ph:  33-1-49-812-590
	Dijon
	Centre de Lutte Contre le Cancer Georges-Francois Leclerc
		Contact Person	Ph:  33-3-8073-7500
	La Roche Sur Yon
	Centre Hospitalier Departemental
		Contact Person	Ph:  33-2-5144-6112
	Le Kremlin - Bicetre
	Centre Hospitalier Universitaire de Bicetre
		Contact Person	Ph:  33-452-12121
	Lille
	Centre Oscar Lambret
		Contact Person	Ph:  33-3-2029-5959
	Lyon
	Centre Leon Berard
		Contact Person	Ph:  33-4-7878-2828
	Marseille
	CHU de la Timone
		Contact Person	Ph:  33-91-385-708
	Metz
	Hopital Clinique Claude Bernard
		Contact Person	Ph:  33-87-396-666
	Montpellier
	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
		Contact Person	Ph:  33-4-6761-3100
	Nantes-Saint Herblain
	Centre Regional Rene Gauducheau
		Contact Person	Ph:  33-2-4067-9900
	Paris
	Hopital Bichat - Claude Bernard
		Contact Person	Ph:  33-01-4025-7000
	Hopital Europeen Georges Pompidou
		Contact Person	Ph:  33-56-09-20-00
	Hopital Tenon
		Contact Person	Ph:  33-1-40-307-000
	Reims
	Institut Jean Godinot
		Contact Person	Ph:  33-03-2650-4444
	Rennes
	Centre Eugene Marquis
		Contact Person	Ph:  33-2-9925-3178
	Saint Nazaire
	Centre Hospitalier General de Saint Nazaire
		Contact Person	Ph:  33-2-4090-6000
	Strasbourg
	Hopitaux Universitaire de Strasbourg
		Contact Person	Ph:  33-3-8811-6768
	Suresnes
	Hopital Foch
		Contact Person	Ph:  33-1-4772-9191
	Toulouse
	Institut Claudius Regaud
		Contact Person	Ph:  33-5-6142-4242
	Vandoeuvre-les-Nancy
	Centre Alexis Vautrin
		Contact Person	Ph:  33-3-8359-8400
	Villejuif
	Institut Gustave Roussy
		Contact Person	Ph:  33-1-4211-4211
Germany
	Blankenhain
	Helios - Klinik Blankenhain
		Contact Person	Ph:  49-3-64-5950
	Frankfurt
	Klinikum der J.W. Goethe Universitaet
		Contact Person	Ph:  49-69-6301-5744
	Fulda
	Klinikum Fulda
		Contact Person	Ph:  49-661-84-54-81
	Kassel
	Klinikum Kassel
		Contact Person	Ph:  49-0561-980-3051
	Krefeld
	St. Josefshospital Uerdingen
		Contact Person	Ph:  49-2151-452-0
	Marburg
	Universitaetsklinikum Giessen und Marburg GmbH - Marburg
		Contact Person	Ph:  49-6421-28-66-308
	Muenster
	Medizinische Klinik und Poliklinik A - Universitaetsklinikum Muenster
		Contact Person	Ph:  49-251-837-586
	Nuernberg
	Klinikum Nuernberg - Klinikum Nord
		Contact Person	Ph:  49-911-398-2460
	Oldenburg
	Klinikum Oldenburg
		Contact Person	Ph:  49-441-403-2611
Israel
	Zerifin
	Assaf Harofeh Medical Center
		Contact Person	Ph:  972-3-964-8040
Italy
	Cuneo
	Ospedale Santa Croce
		Contact Person	Ph:  39-0171-441-309
	Palermo
	Universita Di Palermo
		Contact Person	Ph:  39-91-625-5292
	Rome
	Azienda Ospedaliera S. Camillo-Forlanini
		Contact Person	Ph:  39-5-870-2870
	Varese
	Ospedale di Circolo e Fondazione Macchi
		Contact Person	Ph:  39-332-278-111
Netherlands
	Amsterdam
	Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
		Contact Person	Ph:  31-20-512-9111
	Onze Lieve Vrouwe Gasthuis
		Contact Person	Ph:  31-20-599-9111
	Groningen
	University Medical Center Groningen
		Contact Person	Ph:  31-50-361-2317
	Nijmegen
	Universitair Medisch Centrum St. Radboud - Nijmegen
		Contact Person	Ph:  31-24-361-1111
	Rotterdam
	University Medical Center Rotterdam at Erasmus Medical Center
		Contact Person	Ph:  31-10-463-9222
Norway
	Oslo
	Norwegian Radium Hospital
		Contact Person	Ph:  47-22-93-4000
Poland
	Warsaw
	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw
		Contact Person	Ph:  48-22-546-2169
Sweden
	Uppsala
	Uppsala University Hospital
		Per-Uno Malmstrom, MD	Ph:  18-611-0000
			Email: per-uno.malmstrom@surgsci.uu.se
Switzerland
	Bern
	Inselspital Bern
		Contact Person	Ph:  41-31-632-2243
Turkey
	Istanbul
	Marmara University Hospital
		Contact Person	Ph:  90-216-327-5050
United Kingdom
England
	Bristol
	Bristol Haematology and Oncology Centre
		Contact Person	Ph:  44-117-928-2412
	Cambridge
	Addenbrooke's Hospital
		Contact Person	Ph:  44-1223-24-5151
	Croydon
	Mayday University Hospital
		Contact Person
	Durham
	University Hospital of North Durham
		Contact Person	Ph:  44-0191-333-2333
	Hull
	Princess Royal Hospital at Hull and East Yorkshire NHS Trust
		Contact Person	Ph:  44-1482-701-151
	Leeds
	Leeds Cancer Centre at St. James's University Hospital
		Contact Person	Ph:  44-113-206-4904
	Leicester
	Leicester Royal Infirmary
		Contact Person	Ph:  44-116-254-1414
	London
	Guy's Hospital
		Contact Person	Ph:  44-20-7955-5000
	Saint Bartholomew's Hospital
		Contact Person	Ph:  44-20-7601-8391
	St. Thomas' Hospital
		Contact Person	Ph:  44-20-7928-9292
	Maidstone
	Mid Kent Oncology Centre at Maidstone Hospital
		Contact Person	Ph:  44-1622-729-000
	Manchester
	Christie Hospital
		Contact Person	Ph:  44-845-226-3000
	Newcastle Upon Tyne
	Northern Centre for Cancer Treatment at Newcastle General Hospital
		Contact Person	Ph:  44-191-273-8811
	Northwood
	Mount Vernon Cancer Centre at Mount Vernon Hospital
		Contact Person	Ph:  44-1923-844-533
	Norwich
	Norfolk and Norwich University Hospital
		Contact Person	Ph:  44-603-286-286
	Oxford
	Churchill Hospital
		Contact Person	Ph:  44-186-574-1841
	Plymouth
	Derriford Hospital
		Contact Person	Ph:  44-175-277-7111
	Poole Dorset
	Poole Hospital NHS Trust
		Contact Person	Ph:  44-1202-448-263
	Portsmouth Hants
	Portsmouth Oncology Centre at Saint Mary's Hospital
		Contact Person	Ph:  44-23-9228-6000
	Scunthorpe
	Scunthorpe General Hospital
		Contact Person	Ph:  44-1724-282-282
	Sheffield
	Cancer Research Centre at Weston Park Hospital
		Contact Person	Ph:  44-114-226-5000
	Shrewsbury
	Royal Shrewsbury Hospital
		Contact Person	Ph:  44-1743-261-000
	Southampton
	Royal South Hants Hospital
		Contact Person	Ph:  44-23-8077-7222
	Sunderland
	Sunderland Royal Hospital
		Contact Person	Ph:  44-191-565-6256
	Sutton
	Royal Marsden - Surrey
		Contact Person	Ph:  44-20-8642-6011
	Worthing
	Worthing Hospital
		Contact Person	Ph:  44-1903-205-111
Scotland
	Glasgow
	Gartnavel General Hospital
		Contact Person	Ph:  44-141-211-3242
	Western Infirmary
		Contact Person	Ph:  44-141-211-2000
Wales
	Cardiff
	Velindre Cancer Center at Velindre Hospital
		Contact Person	Ph:  44-29-2031-6292

Registry Information
Official Title		Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients with pT3-pT4, and/or N+MO Transitional Cell Carcinoma (TCC) of the Bladder
Trial Start Date		2001-10-09
Trial Completion Date		2007-01-11 (estimated)
Registered in ClinicalTrials.gov		NCT00028756
Date Submitted to PDQ		2001-10-30
Information Last Verified		2008-04-13