Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer
Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy
9 other identifiers
interventional
608
15 countries
233
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
233 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedFirst Submitted
Initial submission to the registry
August 10, 2001
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedJune 12, 2013
June 1, 2013
3.1 years
August 10, 2001
June 11, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- European Organisation for Research and Treatment of Cancer - EORTClead
- National Cancer Institute (NCI)collaborator
- Groupe D'Etude des Tumeurs Uro-Genitalescollaborator
- Institute of Cancer Research, United Kingdomcollaborator
- Central European Cooperative Oncology Groupcollaborator
- NCIC Clinical Trials Groupcollaborator
- SWOG Cancer Research Networkcollaborator
- German Association of Urologic Oncologycollaborator
- Spanish Oncology Genito-Urinary Groupcollaborator
- Medical Research Councilcollaborator
Study Sites (234)
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, 92868, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80010, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, 60153-5500, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, 66160-7390, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40502-2236, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536-0084, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, 02118, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0330, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202, United States
Providence Cancer Institute at Providence Hospital
Southfield, Michigan, 48075, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, 55805, United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128, United States
CCOP - Kansas City
Kansas City, Missouri, 64131, United States
St. Louis University Hospital Cancer Center
St Louis, Missouri, 63110, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0501, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195-9001, United States
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97201-3098, United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207, United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, 29401-5799, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38103, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104, United States
Harrington Cancer Center
Amarillo, Texas, 79106, United States
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, 79106, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Del Rio, Texas, 78840, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0565, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4095, United States
Southwest Cancer and Research Center at University Medical Center
Lubbock, Texas, 79415-3364, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78229, United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98104, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108, United States
Fremantle Hospital
Fremantle, Western Australia, 6160, Australia
Kaiser Franz Josef Hospital
Vienna, A-1100, Austria
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, B-9300, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, 1090, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, B-2650, Belgium
CHU Liege - Domaine Universitaire du Sart Tilman
Liège, B-4000, Belgium
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Lethbridge Cancer Clinic
Lethbridge, Alberta, T1J 1W5, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
Nanaimo, British Columbia, V9S 2B7, Canada
Lions Gate Hospital
North Vancouver, British Columbia, V7L 2P9, Canada
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, V5Z 3J5, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
Providence Health Care - Vancouver
Vancouver, British Columbia, V6Z 1Y6, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5, Canada
G. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6ZB, Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, E1C 8X3, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7, Canada
Cape Breton Cancer Centre
Sydney, Nova Scotia, B1P 1P3, Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, L4M 6M2, Canada
William Osler Health Centre
Brampton, Ontario, L6W 2Z8, Canada
Northeastern Ontario Regional Cancer Centre - Sudbury
Greater Sudbury, Ontario, P3E 5J1, Canada
Hamilton and District Urology Association
Hamilton, Ontario, L8N 1T8, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9, Canada
Grand River Regional Cancer Centre
Kitchner, Ontario, N2G 1G3, Canada
London Health Sciences Centre
London, Ontario, N6A 4G5, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
Markham Stouffville Hospital
Markham, Ontario, L6B IAI, Canada
Trillium Health Centre
Mississauga, Ontario, L5B 1B8, Canada
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9, Canada
North York General Hospital, Ontario
North York, Ontario, M2K 1E1, Canada
Sunnybrook and Women's College Health Sciences Centre
North York, Ontario, M4N 3M5, Canada
Male Health Centre - Oakville
Oakville, Ontario, L6H 3PI, Canada
Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4, Canada
Peterborough Oncology Clinic
Peterborough, Ontario, K9H 7B6, Canada
Algoma Reginal Cancer Program at Sault Area Hospital
Sault Ste. Marie, Ontario, P6B 1Y5, Canada
Scarborough Hospital - General Site
Scarborough Village, Ontario, M1P 2V5, Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, L2R 5K3, Canada
Northwestern Ontario Regional Cancer Care
Thunder Bay, Ontario, P7B 6V4, Canada
Toronto East General Hospital
Toronto, Ontario, M4C 3E7, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, M5B 1W8, Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, M5G 1X5, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Male Health Centre - North York
Toronto, Ontario, M6A 3B5, Canada
St. Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5, Canada
Humber River Regional Hospital - Weston
Weston, Ontario, M9N 1N8, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
Prince Edward Island Cancer Center at Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, C1A 8T5, Canada
Complexe Hospitalier de la Sagamie
Chicoutimi, Quebec, G7H 5H6, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, J1H 5N4, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1, Canada
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, J6E 6J2, Canada
Hotel-Dieu de Levis
Lévis, Quebec, G6V 3Z1, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, H1T 2M4, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L-4M1, Canada
McGill University
Montreal, Quebec, H2W 1S6, Canada
Hotel Dieu de Montreal
Montreal, Quebec, H2W 1T8, Canada
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, G1R 2J6, Canada
Centre Hospitalier Regional de Rimouski
Québec, Quebec, G1S 4L8, Canada
Hopital du Saint-Sacrement, Quebec
Québec, Quebec, G1S 4L8, Canada
L'Hopital Laval
Ste-Foy, Quebec, G1V 4G5, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Aarhus Kommunehospital
Aarhus, DK-8000, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Centre Paul Papin
Angers, 49036, France
Institut Bergonie
Bordeaux, 33076, France
Centre Hospitalier Docteur Duchenne
Boulogne-sur-Mer, 62200, France
Centre Regional Francois Baclesse
Caen, 14076, France
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94010, France
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, 21079, France
CHU de Grenoble - Hopital de la Tronche
Grenoble, 38043, France
Centre Hospitalier Departemental
La Roche-sur-Yon, F-85025, France
Centre Oscar Lambret
Lille, 59020, France
Centre Leon Berard
Lyon, 69373, France
CHU de la Timone
Marseille, 13385, France
Hopital Lapeyronie-CHU Montpellier
Montpellier, 34295, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298, France
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, 44805, France
Hopital Europeen Georges Pompidou
Paris, 75015, France
Institut Curie - Section Medicale
Paris, 75248, France
Hopital Tenon
Paris, 75970, France
Centre Eugene Marquis
Rennes, 35042, France
Centre Henri Becquerel
Rouen, 76038, France
Centre Rene Huguenin
Saint-Cloud, 92211, France
Centre Medico-Chirurgical Foch
Suresnes, 92151, France
Centre Antoine Lacassagne
Toulouse, 31052, France
Institut Claudius Regaud
Toulouse, 31052, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511, France
Krankenhaus Hohe Warte Mediziniche Klinik
Bayreuth, 95445, Germany
Charite Humboldt - University Berlin
Berlin, D-10117, Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, D-12200, Germany
Helios - Klinik Blankenhain
Blankenhain, 99444, Germany
Universitaetsklinikum Bonn
Bonn, D-53105, Germany
Staedtische Kliniken Dortmund
Dortmund, 44143, Germany
Universitaetsklinik Duesseldorf
Düsseldorf, D-40225, Germany
St. Markus Krankenhaus
Frankfurt, 60431, Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, D-60590, Germany
Klinikum Fulda
Fulda, D-36013, Germany
Martin Luther Universitaet
Halle, D-06097, Germany
Marienkrankenhaus
Hamburg, 22087, Germany
Universitat des Saarlandes Innere Medizin 1
Hamburg, D-66421, Germany
Klinikum der Friedrich-Schiller Universitaet Jena
Jena, D-07740, Germany
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen am Rhein, D-67063, Germany
Staedtisches Krankenhaus Sued
Lübeck, 23560, Germany
Medizinische Universitaet Luebeck
Lübeck, D-23538, Germany
Kreiskrankenhaus Luedenscheid
Lüdenscheid, 58515, Germany
Klinikum der Stadt Mannheim
Mannheim, D-68135, Germany
University of Marburg
Marburg, D-35033, Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, D-81675, Germany
Klinik und Poliklinik fuer Kinderheilkunde
Münster, D-48129, Germany
Klinikum Neubrandenburg
Neubrandenburg, 17036, Germany
Klinikum Nuernberg - Klinikum Nord
Nuremberg, D-90419, Germany
Paracelsus Karankenhaus Ruit
Ostfildern, 73760, Germany
Asklepios Klinik Pasewalk
Pasewalk, 17309, Germany
Diakonie - Krankenhaus
Rotenburg (Wümme), DOH-27356, Germany
Johanniter Kankenhaus Stendal
Stendal, 39576, Germany
Katharinenhospital
Stuttgart, D-70174, Germany
Universitaetsklinikum Tuebingen
Tübingen, D-72076, Germany
Universitaet Ulm
Ulm, D-89075, Germany
Klinikum der Stadt Wolfsburg
Wolfsburg, D-38440, Germany
Klinikum St. Marien
Wuppertal, D-42283, Germany
Witten University - Klinikum Wuppertal
Wuppertal, D-42283, Germany
National Institute of Oncology
Budapest, 1125, Hungary
Rabin Medical Center - Beilinson Campus
Petah Tikva, 49100, Israel
Assaf Harofeh Medical Center
Ẕerifin, 70300, Israel
Ospedale Santa Croce
Cuneo, 12100, Italy
Istituto Scientifico H.San Raffaele
Milan, 20132, Italy
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, 1066 CX, Netherlands
Jeroen Bosch Ziekenhuis
NL'S Hertogenbosch, NL-5211, Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, 3008 AE, Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, 3584 CX, Netherlands
University Hospital - Rotterdam Dijkzigt
Utrecht, 3584 CX, Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, 02-781, Poland
National Cancer Institute - Bratislava
Bratislava, 833 10, Slovakia
Hospital Juan Canalejo
A Coruña, 15006, Spain
Hospital Arquitecto Marcide
A Coruña, 15405, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, 08916, Spain
Hospital Del Mar
Barcelona, 08003, Spain
Hospital Clinic y Provincial de Barcelona
Barcelona, 08036, Spain
Hospital General Universitari Vall d'Hebron
Barcelona, 08036, Spain
Hospital General Universitario De Guadalajara
Guadalajara, 19002, Spain
Hospital Cuidad de Jaen
Jaén, E-23006, Spain
Hospital Universitario San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Clinico Universitario - Malaga
Málaga, 29010, Spain
Hospital Son Dureta
Palma de Mallorca, 07014, Spain
Hospsital de Sabadell
Sabadell, 08208, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Hospital Consorci Sanitari De Terrassa
Terrassa, 08227, Spain
Instituto Valenciano De Oncologia
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Rio Hortega
Valladolid, 47010, Spain
Hospital General De Vic
Vic, 08500, Spain
Hospital Clinico Universitario
Zaragoza, 50009, Spain
Princess Royal Hospital
Hull, England, HU8 9HE, United Kingdom
St. James's University Hospital
Leeds, England, LS9 7TF, United Kingdom
Saint Bartholomew's Hospital
London, England, EC1A 7BE, United Kingdom
Guy's and St. Thomas' Hospitals NHS Trust
London, England, SE1 9RT, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE, United Kingdom
Royal South Hants Hospital
Southampton, England, SO14 0YG, United Kingdom
Royal Marsden Hospital - Sutton
Sutton, England, SM2 5PT, United Kingdom
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, CF14 2TL, United Kingdom
Related Publications (1)
Bellmunt J, von der Maase H, Mead GM, et al.: Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine (PCG) and gemcitabine/cisplatin (GC) in patients with locally advanced (LA) or metastatic (M) urothelial cancer without prior systemic therapy: EORTC30987/Intergroup study. [Abstract] J Clin Oncol 25 (Suppl 18): A-LBA5030, 242s, 2007.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Joaquim Bellmunt, MD, PhD
Vall d'Hebron University Hospital
- STUDY CHAIR
Stephane Culine, MD
Institut du Cancer de Montpellier - Val d'Aurelle
- STUDY CHAIR
Michael Leahy, MBChB, FRACP, FRCP, FRC Path
Fremantle Hospital
- STUDY CHAIR
Christoph Zielinski, MD
Allgemeines Krankenhaus - Universitatskliniken
- STUDY CHAIR
Malcolm J. Moore, MD
Princess Margaret Hospital, Canada
- STUDY CHAIR
David C. Smith, MD
University of Michigan Rogel Cancer Center
- STUDY CHAIR
Andreas Boehle, MD
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
- STUDY CHAIR
Jose Baselga, MD
Vall d'Hebron University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2001
First Posted
January 27, 2003
Study Start
May 1, 2001
Primary Completion
June 1, 2004
Last Updated
June 12, 2013
Record last verified: 2013-06