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Last Modified: 4/6/2009     First Published: 1/1/2002  
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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

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActiveNot specifiedNCI, OtherEORTC-30994
ACOSOG-EORTC-30994, CAN-NCIC-EORTC-30994, FNCLCC-GETUG-EORTC-30994, NORDIC-EORTC-30994, UKCCCR-EORTC-30994, NCRI-BLADDER-EORTC-30994, NCT00028756

Objectives

  1. Compare the overall and progression-free survival of patients with stage III or IV transitional cell carcinoma of the bladder urothelium treated with immediate versus deferred adjuvant chemotherapy after radical cystectomy.

Entry Criteria

Disease Characteristics:

  • Histologically confirmed transitional cell carcinoma of the bladder urothelium
    • T3-4, N1-3, M0

  • No pure squamous cell or adenocarcinoma tumors

  • No more than 90 days since prior radical cystectomy and bilateral lymphadenectomy without evidence of microscopic residual disease

Prior/Concurrent Therapy:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior systemic chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy to the bladder

Surgery:

  • See Disease Characteristics

Patient Characteristics:

Age:

  • Not specified

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,500/mm3
  • Platelet count at least 120,000/mm3

Hepatic:

  • SGOT/SGPT less than 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 2.5 times ULN
  • Bilirubin normal

Renal:

  • Glomerular filtration rate greater than 60 mL/min

Cardiovascular:

  • No clinically significant cardiac arrhythmia
  • No congestive heart failure
  • No complete bundle branch block
  • No New York Heart Association class III or IV heart disease

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after study
  • Considered fit for cisplatin-containing combination chemotherapy
  • No clinically abnormal auditory function
  • No known hypersensitivity to E. coli-derived drug preparations
  • No grade 2 or greater peripheral neuropathy
  • No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix, treated basal cell skin cancer, or treated incidental prostate cancer (pT2, Gleason score no greater than 6, and PSA less than 0.5 ng/mL)
  • No psychological, familial, sociological, or geographical condition that would preclude study involvement

Expected Enrollment

660

A total of 660 will be accrued for this study.

Outcomes

Primary Outcome(s)

Duration of survival

Secondary Outcome(s)

Duration of progression-free survival

Outline

This is a randomized, multicenter study. Patients are stratified according to participating center, tumor status (pT1-2 vs pT3 vs pT4), and node status (node positive vs node negative with 15 or more nodes sampled vs node negative with less than 15 nodes sampled). Patients are randomized to one of two treatment arms.

  • Arm I: Beginning within 90 days of radical cystectomy, patients receive a total of 4 courses of adjuvant chemotherapy.

  • Arm II: Beginning at the time of clinical relapse, patients receive a total of 6 courses of adjuvant chemotherapy.

Patients in both arms receive one of the following chemotherapy regimens to be determined by participating center:

  • Regimen A (Classical M-VAC): Patients receive classical M-VAC comprising methotrexate IV on days 1, 15, and 22; vinblastine IV on days 2, 15, and 22; and doxorubicin IV and cisplatin IV on day 2. Courses repeat every 28 days.

  • Regimen B (High-dose M-VAC): Patients receive high-dose M-VAC comprising methotrexate IV on day 1 and vinblastine IV, doxorubicin IV, and cisplatin IV on day 2. Patients also receive filgrastim (G-CSF) subcutaneously once daily on days 4-10. Courses repeat every 14 days.

  • Regimen C (Gemcitabine and cisplatin): Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 followed by cisplatin IV on day 1 or 2. Courses repeat every 28 days.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

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

Trial Sites

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
 Dorset Cancer Centre
 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 2009-06-14

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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