Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer
NCT ID: NCT00022191
Last Updated: 2013-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
608 participants
INTERVENTIONAL
2001-05-31
Brief Summary
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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.
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Detailed Description
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* Compare the duration of survival of patients with stage IV transitional cell carcinoma of the urothelium treated with cisplatin and gemcitabine with or without paclitaxel.
* Compare the duration of progression-free survival, response rates, and duration of response in patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, WHO performance status (0 vs 1), and presence of metastatic disease (yes vs no). Patients are randomized to one of two treatment arms.
* Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 1 hour on day 1 or 2. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive paclitaxel IV over 1 hour on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for at least 3 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 610 patients (305 per treatment arm) will be accrued for this study within 3.04 years.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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cisplatin
gemcitabine hydrochloride
paclitaxel
Eligibility Criteria
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Inclusion Criteria
* No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* WHO 0-1
Life expectancy:
* At least 12 weeks
Hematopoietic:
* WBC at least 3,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Bilirubin less than 1.25 times normal
* AST or ALT less than 2.5 times normal
Renal:
* Glomerular filtration rate at least 60 mL/min
* Calcium normal or clinically insignificant
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
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
* No grade 3 or 4 infection without neutropenia
* No other serious concurrent systemic disorder that would preclude study therapy
* No mental disorder that would preclude study compliance
* No grade II or greater neuropathy
* No other prior or concurrent malignancy except appropriately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or incidental prostate cancer (T1, Gleason score no greater than 6, and PSA less than 0.5 ng/mL)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior investigational biologic agents (e.g., antiangiogenic products, signal transduction pathway inhibitors, immunomodulators, or monoclonal antibody therapy)
* At least 4 weeks since prior immunotherapy
Chemotherapy:
* No prior systemic chemotherapy
* At least 4 weeks since prior local intravesical chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* No more than 1 prior course of radiotherapy
* At least 4 weeks since prior radiotherapy and recovered
Surgery:
* See Disease Characteristics
* Prior urological procedures to relieve urinary tract obstruction and improve renal function allowed (e.g., ureteral stent or percutaneous nephrostomy)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Groupe D'Etude des Tumeurs Uro-Genitales
OTHER
Institute of Cancer Research, United Kingdom
OTHER
Central European Cooperative Oncology Group
OTHER
NCIC Clinical Trials Group
NETWORK
SWOG Cancer Research Network
NETWORK
German Association of Urologic Oncology
OTHER
Spanish Oncology Genito-Urinary Group
OTHER
Medical Research Council
OTHER_GOV
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Joaquim Bellmunt, MD, PhD
Role: STUDY_CHAIR
Vall d'Hebron University Hospital
Stephane Culine, MD
Role: STUDY_CHAIR
Institut du Cancer de Montpellier - Val d'Aurelle
Michael Leahy, MBChB, FRACP, FRCP, FRC Path
Role: STUDY_CHAIR
Fremantle Hospital
Christoph Zielinski, MD
Role: STUDY_CHAIR
Allgemeines Krankenhaus - Universitatskliniken
Malcolm J. Moore, MD
Role: STUDY_CHAIR
Princess Margaret Hospital, Canada
David C. Smith, MD
Role: STUDY_CHAIR
University of Michigan Rogel Cancer Center
Andreas Boehle, MD
Role: STUDY_CHAIR
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Jose Baselga, MD
Role: STUDY_CHAIR
Vall d'Hebron University Hospital
Locations
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Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
Providence Cancer Institute at Providence Hospital
Southfield, Michigan, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
St. Louis University Hospital Cancer Center
St Louis, Missouri, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, United States
Harrington Cancer Center
Amarillo, Texas, United States
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Del Rio, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Southwest Cancer and Research Center at University Medical Center
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
Fremantle Hospital
Fremantle, Western Australia, Australia
Kaiser Franz Josef Hospital
Vienna, , Austria
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, , Belgium
Institut Jules Bordet
Brussels, , Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
CHU Liege - Domaine Universitaire du Sart Tilman
Liège, , Belgium
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Lethbridge Cancer Clinic
Lethbridge, Alberta, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada
Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
Nanaimo, British Columbia, Canada
Lions Gate Hospital
North Vancouver, British Columbia, Canada
Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
Providence Health Care - Vancouver
Vancouver, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada
G. Steinhoff Clinical Research
Victoria, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Moncton Hospital
Moncton, New Brunswick, Canada
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada
Saint John Regional Hospital
Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation
St. John's, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Cape Breton Cancer Centre
Sydney, Nova Scotia, Canada
Royal Victoria Hospital, Barrie
Barrie, Ontario, Canada
William Osler Health Centre
Brampton, Ontario, Canada
Northeastern Ontario Regional Cancer Centre - Sudbury
Greater Sudbury, Ontario, Canada
Hamilton and District Urology Association
Hamilton, Ontario, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
Kingston Regional Cancer Centre
Kingston, Ontario, Canada
Grand River Regional Cancer Centre
Kitchner, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Markham Stouffville Hospital
Markham, Ontario, Canada
Trillium Health Centre
Mississauga, Ontario, Canada
Credit Valley Hospital
Mississauga, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
North York General Hospital, Ontario
North York, Ontario, Canada
Sunnybrook and Women's College Health Sciences Centre
North York, Ontario, Canada
Male Health Centre - Oakville
Oakville, Ontario, Canada
Durham Regional Cancer Centre at Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
Peterborough Oncology Clinic
Peterborough, Ontario, Canada
Algoma Reginal Cancer Program at Sault Area Hospital
Sault Ste. Marie, Ontario, Canada
Scarborough Hospital - General Site
Scarborough Village, Ontario, Canada
Hotel Dieu Health Sciences Hospital - Niagara
St. Catharines, Ontario, Canada
Northwestern Ontario Regional Cancer Care
Thunder Bay, Ontario, Canada
Toronto East General Hospital
Toronto, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada
Mount Sinai Hospital - Toronto
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Male Health Centre - North York
Toronto, Ontario, Canada
St. Joseph's Health Centre - Toronto
Toronto, Ontario, Canada
Humber River Regional Hospital - Weston
Weston, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
Windsor, Ontario, Canada
Prince Edward Island Cancer Center at Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, Canada
Complexe Hospitalier de la Sagamie
Chicoutimi, Quebec, Canada
CHUS-Hopital Fleurimont
Fleurimont, Quebec, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
Centre Hospitalier Regional de Lanaudiere
Joliette, Quebec, Canada
Hotel-Dieu de Levis
Lévis, Quebec, Canada
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Hotel Dieu de Montreal
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Québec, Quebec, Canada
Centre Hospitalier Regional de Rimouski
Québec, Quebec, Canada
Hopital du Saint-Sacrement, Quebec
Québec, Quebec, Canada
L'Hopital Laval
Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Aarhus Kommunehospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Centre Paul Papin
Angers, , France
Institut Bergonie
Bordeaux, , France
Centre Hospitalier Docteur Duchenne
Boulogne-sur-Mer, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Hospitalier Universitaire Henri Mondor
Créteil, , France
Centre de Lutte Contre le Cancer, Georges-Francois Leclerc
Dijon, , France
CHU de Grenoble - Hopital de la Tronche
Grenoble, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
CHU de la Timone
Marseille, , France
Hopital Lapeyronie-CHU Montpellier
Montpellier, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, , France
Hopital Europeen Georges Pompidou
Paris, , France
Institut Curie - Section Medicale
Paris, , France
Hopital Tenon
Paris, , France
Centre Eugene Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Centre Rene Huguenin
Saint-Cloud, , France
Centre Medico-Chirurgical Foch
Suresnes, , France
Centre Antoine Lacassagne
Toulouse, , France
Institut Claudius Regaud
Toulouse, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Krankenhaus Hohe Warte Mediziniche Klinik
Bayreuth, , Germany
Charite Humboldt - University Berlin
Berlin, , Germany
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
Helios - Klinik Blankenhain
Blankenhain, , Germany
Universitaetsklinikum Bonn
Bonn, , Germany
Staedtische Kliniken Dortmund
Dortmund, , Germany
Universitaetsklinik Duesseldorf
Düsseldorf, , Germany
St. Markus Krankenhaus
Frankfurt, , Germany
Klinikum der J.W. Goethe Universitaet
Frankfurt, , Germany
Klinikum Fulda
Fulda, , Germany
Martin Luther Universitaet
Halle, , Germany
Marienkrankenhaus
Hamburg, , Germany
Universitat des Saarlandes Innere Medizin 1
Hamburg, , Germany
Klinikum der Friedrich-Schiller Universitaet Jena
Jena, , Germany
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen am Rhein, , Germany
Staedtisches Krankenhaus Sued
Lübeck, , Germany
Medizinische Universitaet Luebeck
Lübeck, , Germany
Kreiskrankenhaus Luedenscheid
Lüdenscheid, , Germany
Klinikum der Stadt Mannheim
Mannheim, , Germany
University of Marburg
Marburg, , Germany
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, , Germany
Klinik und Poliklinik fuer Kinderheilkunde
Münster, , Germany
Klinikum Neubrandenburg
Neubrandenburg, , Germany
Klinikum Nuernberg - Klinikum Nord
Nuremberg, , Germany
Paracelsus Karankenhaus Ruit
Ostfildern, , Germany
Asklepios Klinik Pasewalk
Pasewalk, , Germany
Diakonie - Krankenhaus
Rotenburg (Wümme), , Germany
Johanniter Kankenhaus Stendal
Stendal, , Germany
Katharinenhospital
Stuttgart, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Universitaet Ulm
Ulm, , Germany
Klinikum der Stadt Wolfsburg
Wolfsburg, , Germany
Klinikum St. Marien
Wuppertal, , Germany
Witten University - Klinikum Wuppertal
Wuppertal, , Germany
National Institute of Oncology
Budapest, , Hungary
Rabin Medical Center - Beilinson Campus
Petah Tikva, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Ospedale Santa Croce
Cuneo, , Italy
Istituto Scientifico H.San Raffaele
Milan, , Italy
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, , Netherlands
Jeroen Bosch Ziekenhuis
NL'S Hertogenbosch, , Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, , Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , Netherlands
University Hospital - Rotterdam Dijkzigt
Utrecht, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , Poland
National Cancer Institute - Bratislava
Bratislava, , Slovakia
Hospital Juan Canalejo
A Coruña, , Spain
Hospital Arquitecto Marcide
A Coruña, , Spain
Hospital Universitari Germans Trias i Pujol
Badalona, , Spain
Hospital Del Mar
Barcelona, , Spain
Hospital Clinic y Provincial de Barcelona
Barcelona, , Spain
Hospital General Universitari Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario De Guadalajara
Guadalajara, , Spain
Hospital Cuidad de Jaen
Jaén, , Spain
Hospital Universitario San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Clinico Universitario - Malaga
Málaga, , Spain
Hospital Son Dureta
Palma de Mallorca, , Spain
Hospsital de Sabadell
Sabadell, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Consorci Sanitari De Terrassa
Terrassa, , Spain
Instituto Valenciano De Oncologia
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Rio Hortega
Valladolid, , Spain
Hospital General De Vic
Vic, , Spain
Hospital Clinico Universitario
Zaragoza, , Spain
Princess Royal Hospital
Hull, England, United Kingdom
St. James's University Hospital
Leeds, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Guy's and St. Thomas' Hospitals NHS Trust
London, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Royal South Hants Hospital
Southampton, England, United Kingdom
Royal Marsden Hospital - Sutton
Sutton, England, United Kingdom
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, United Kingdom
Countries
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References
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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.
Other Identifiers
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EORTC-30987
Identifier Type: -
Identifier Source: secondary_id
CAN-NCIC-BL7
Identifier Type: -
Identifier Source: secondary_id
CECOG-EORTC-30987
Identifier Type: -
Identifier Source: secondary_id
GAUO-EORTC-30987
Identifier Type: -
Identifier Source: secondary_id
GETUG-EORTC-30987
Identifier Type: -
Identifier Source: secondary_id
SOGUG-EORTC-30987
Identifier Type: -
Identifier Source: secondary_id
SWOG-30987
Identifier Type: -
Identifier Source: secondary_id
NCRI-CRUK-BA11
Identifier Type: -
Identifier Source: secondary_id
MRC-BA11
Identifier Type: -
Identifier Source: secondary_id
EORTC-30987
Identifier Type: -
Identifier Source: org_study_id
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