Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC (Other)
Overall Status
Completed
CT.gov ID
NCT00022191
Collaborator
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 (Other), Southwest Oncology Group (Other), German Association of Urologic Oncology (Other), Spanish Oncology Genito-Urinary Group (Other), Medical Research Council (Other)
608
234
2.6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
OBJECTIVES:
-
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
608 participants
Allocation:
Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients With Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy
Study Start Date
:
May 1, 2001
Actual Primary Completion Date
:
Jun 1, 2004
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
-
Histologically confirmed stage IV transitional cell carcinoma of the urothelium (pure or mixed) including bladder, urethra, ureter, and renal pelvis
-
T4b, any N OR any T, N2-3 OR M1
-
Ineligible for surgery or radiotherapy with curative intent
-
Measurable or evaluable disease
-
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Veterans Affairs Medical Center - Tucson | Tucson | Arizona | United States | 85723 |
| 2 | Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | United States | 85724 |
| 3 | Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas | United States | 72205 |
| 4 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010-3000 |
| 5 | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | United States | 90033 |
| 6 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1781 |
| 7 | Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | United States | 94553 |
| 8 | Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center | Orange | California | United States | 92868 |
| 9 | University of California Davis Cancer Center | Sacramento | California | United States | 95817 |
| 10 | University of Colorado Cancer Center at University of Colorado Health Sciences Center | Aurora | Colorado | United States | 80010 |
| 11 | Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois | United States | 60141 |
| 12 | Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | United States | 60153-5500 |
| 13 | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7390 |
| 14 | Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | United States | 40502-2236 |
| 15 | Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | United States | 40536-0084 |
| 16 | Tulane University School of Medicine | New Orleans | Louisiana | United States | 70112 |
| 17 | Veterans Affairs Medical Center - New Orleans | New Orleans | Louisiana | United States | 70112 |
| 18 | Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | United States | 71130-3932 |
| 19 | Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | United States | 71130 |
| 20 | Cancer Research Center at Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 21 | Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan | United States | 48105 |
| 22 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0330 |
| 23 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201-1379 |
| 24 | Josephine Ford Cancer Center at Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 25 | Providence Cancer Institute at Providence Hospital | Southfield | Michigan | United States | 48075 |
| 26 | St. Mary's - Duluth Clinic Cancer Center | Duluth | Minnesota | United States | 55805 |
| 27 | Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi | United States | 39531-2410 |
| 28 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
| 29 | Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | United States | 39216 |
| 30 | Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri | United States | 64128 |
| 31 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
| 32 | St. Louis University Hospital Cancer Center | Saint Louis | Missouri | United States | 63110 |
| 33 | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | United States | 10032 |
| 34 | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 35 | Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | United States | 45220-2288 |
| 36 | Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | United States | 45267-0501 |
| 37 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195-9001 |
| 38 | Oklahoma University Medical Center at University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 39 | Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma | United States | 73104 |
| 40 | Cancer Institute at Oregon Health and Science University | Portland | Oregon | United States | 97201-3098 |
| 41 | Veterans Affairs Medical Center - Portland | Portland | Oregon | United States | 97207 |
| 42 | Veterans Affairs Medical Center - Charleston | Charleston | South Carolina | United States | 29401-5799 |
| 43 | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 44 | University of Tennessee Cancer Institute | Memphis | Tennessee | United States | 38103 |
| 45 | Veterans Affairs Medical Center - Memphis | Memphis | Tennessee | United States | 38104 |
| 46 | Harrington Cancer Center | Amarillo | Texas | United States | 79106 |
| 47 | Veterans Affairs Medical Center - Amarillo | Amarillo | Texas | United States | 79106 |
| 48 | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Del Rio | Texas | United States | 78840 |
| 49 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234-6200 |
| 50 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0565 |
| 51 | University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030-4095 |
| 52 | Southwest Cancer and Research Center at University Medical Center | Lubbock | Texas | United States | 79415-3364 |
| 53 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229-3900 |
| 54 | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | United States | 78229 |
| 55 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112-5550 |
| 56 | Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | United States | 84148 |
| 57 | Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | United States | 98104 |
| 58 | Veterans Affairs Medical Center - Seattle | Seattle | Washington | United States | 98108 |
| 59 | Fremantle Hospital | Fremantle | Western Australia | Australia | 6160 |
| 60 | Kaiser Franz Josef Hospital | Vienna | Austria | A-1100 | |
| 61 | Onze Lieve Vrouw Ziekenhuis Aalst | Aalst | Belgium | B-9300 | |
| 62 | Institut Jules Bordet | Brussels | Belgium | 1000 | |
| 63 | Academisch Ziekenhuis der Vrije Universiteit Brussel | Brussels | Belgium | 1090 | |
| 64 | Universitair Ziekenhuis Antwerpen | Edegem | Belgium | B-2650 | |
| 65 | CHU Liege - Domaine Universitaire du Sart Tilman | Liege | Belgium | B-4000 | |
| 66 | Tom Baker Cancer Center - Calgary | Calgary | Alberta | Canada | T2N 4N2 |
| 67 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G 1Z2 |
| 68 | Lethbridge Cancer Clinic | Lethbridge | Alberta | Canada | T1J 1W5 |
| 69 | British Columbia Cancer Agency - Centre for the Southern Interior | Kelowna | British Columbia | Canada | V1Y 5L3 |
| 70 | Nanaimo Cancer Clinic at Nanaimo Regional General Hospital | Nanaimo | British Columbia | Canada | V9S 2B7 |
| 71 | Lions Gate Hospital | North Vancouver | British Columbia | Canada | V7L 2P9 |
| 72 | Prostate Centre at Vancouver General Hospital | Vancouver | British Columbia | Canada | V5Z 3J5 |
| 73 | British Columbia Cancer Agency | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 74 | Providence Health Care - Vancouver | Vancouver | British Columbia | Canada | V6Z 1Y6 |
| 75 | British Columbia Cancer Agency - Vancouver Island Cancer Centre | Victoria | British Columbia | Canada | V8R 6V5 |
| 76 | G. Steinhoff Clinical Research | Victoria | British Columbia | Canada | V8V 3N1 |
| 77 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 78 | Moncton Hospital | Moncton | New Brunswick | Canada | E1C 6ZB |
| 79 | Doctor Leon Richard Oncology Centre | Moncton | New Brunswick | Canada | E1C 8X3 |
| 80 | Saint John Regional Hospital | Saint John | New Brunswick | Canada | E2L 4L2 |
| 81 | Newfoundland Cancer Treatment and Research Foundation | St. Johns | Newfoundland and Labrador | Canada | A1B 3V6 |
| 82 | Nova Scotia Cancer Centre | Halifax | Nova Scotia | Canada | B3H 1V7 |
| 83 | Cape Breton Cancer Centre | Sydney | Nova Scotia | Canada | B1P 1P3 |
| 84 | Royal Victoria Hospital, Barrie | Barrie | Ontario | Canada | L4M 6M2 |
| 85 | William Osler Health Centre | Brampton | Ontario | Canada | L6W 2Z8 |
| 86 | Hamilton and District Urology Association | Hamilton | Ontario | Canada | L8N 1T8 |
| 87 | Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
| 88 | Kingston Regional Cancer Centre | Kingston | Ontario | Canada | K7L 5P9 |
| 89 | Grand River Regional Cancer Centre | Kitchner | Ontario | Canada | N2G 1G3 |
| 90 | London Health Sciences Centre | London | Ontario | Canada | N6A 4G5 |
| 91 | Cancer Care Ontario-London Regional Cancer Centre | London | Ontario | Canada | N6A 4L6 |
| 92 | Markham Stouffville Hospital | Markham | Ontario | Canada | L6B IAI |
| 93 | Trillium Health Centre | Mississauga | Ontario | Canada | L5B 1B8 |
| 94 | Credit Valley Hospital | Mississauga | Ontario | Canada | L5M 2N1 |
| 95 | Southlake Regional Health Centre | Newmarket | Ontario | Canada | L3Y 2P9 |
| 96 | North York General Hospital, Ontario | North York | Ontario | Canada | M2K 1E1 |
| 97 | Sunnybrook and Women's College Health Sciences Centre | North York | Ontario | Canada | M4N 3M5 |
| 98 | Male Health Centre - Oakville | Oakville | Ontario | Canada | L6H 3PI |
| 99 | Durham Regional Cancer Centre at Lakeridge Health Oshawa | Oshawa | Ontario | Canada | L1G 2B9 |
| 100 | Ottawa Regional Cancer Centre | Ottawa | Ontario | Canada | K1H 1C4 |
| 101 | Peterborough Oncology Clinic | Peterborough | Ontario | Canada | K9H 7B6 |
| 102 | Algoma Reginal Cancer Program at Sault Area Hospital | Sault Sainte Marie | Ontario | Canada | P6B 1Y5 |
| 103 | Scarborough Hospital - General Site | Scarborough | Ontario | Canada | M1P 2V5 |
| 104 | Hotel Dieu Health Sciences Hospital - Niagara | St. Catharines | Ontario | Canada | L2R 5K3 |
| 105 | Northeastern Ontario Regional Cancer Centre - Sudbury | Sudbury | Ontario | Canada | P3E 5J1 |
| 106 | Northwestern Ontario Regional Cancer Care | Thunder Bay | Ontario | Canada | P7B 6V4 |
| 107 | Toronto East General Hospital | Toronto | Ontario | Canada | M4C 3E7 |
| 108 | Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 109 | St. Michael's Hospital - Toronto | Toronto | Ontario | Canada | M5B 1W8 |
| 110 | Mount Sinai Hospital - Toronto | Toronto | Ontario | Canada | M5G 1X5 |
| 111 | Toronto General Hospital | Toronto | Ontario | Canada | M5G 2C4 |
| 112 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 113 | Male Health Centre - North York | Toronto | Ontario | Canada | M6A 3B5 |
| 114 | St. Joseph's Health Centre - Toronto | Toronto | Ontario | Canada | M6R 1B5 |
| 115 | Humber River Regional Hospital - Weston | Weston | Ontario | Canada | M9N 1N8 |
| 116 | Cancer Care Ontario - Windsor Regional Cancer Centre | Windsor | Ontario | Canada | N8W 2X3 |
| 117 | Prince Edward Island Cancer Center at Queen Elizabeth Hospital | Charlottetown | Prince Edward Island | Canada | C1A 8T5 |
| 118 | Complexe Hospitalier de la Sagamie | Chicoutimi | Quebec | Canada | G7H 5H6 |
| 119 | CHUS-Hopital Fleurimont | Fleurimont | Quebec | Canada | J1H 5N4 |
| 120 | Hopital Charles Lemoyne | Greenfield Park | Quebec | Canada | J4V 2H1 |
| 121 | Centre Hospitalier Regional de Lanaudiere | Joliette | Quebec | Canada | J6E 6J2 |
| 122 | Hotel-Dieu de Levis | Levis | Quebec | Canada | G6V 3Z1 |
| 123 | Maisonneuve-Rosemont Hospital | Montreal | Quebec | Canada | H1T 2M4 |
| 124 | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | Canada | H2L-4M1 |
| 125 | McGill University | Montreal | Quebec | Canada | H2W 1S6 |
| 126 | Hotel Dieu de Montreal | Montreal | Quebec | Canada | H2W 1T8 |
| 127 | Hopital Sainte Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 128 | Hopital Du Sacre-Coeur de Montreal | Montreal | Quebec | Canada | H4J 1C5 |
| 129 | Centre Hospitalier Universitaire de Quebec | Quebec City | Quebec | Canada | G1R 2J6 |
| 130 | Hopital du Saint-Sacrement, Quebec | Quebec City | Quebec | Canada | G1S 4L8 |
| 131 | L'Hopital Laval | Ste-Foy | Quebec | Canada | G1V 4G5 |
| 132 | Allan Blair Cancer Centre | Regina | Saskatchewan | Canada | S4T 7T1 |
| 133 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
| 134 | Centre Hospitalier Regional de Rimouski | Quebec | Canada | G1S 4L8 | |
| 135 | Aarhus Kommunehospital | Aarhus | Denmark | DK-8000 | |
| 136 | Rigshospitalet | Copenhagen | Denmark | 2100 | |
| 137 | Centre Paul Papin | Angers | France | 49036 | |
| 138 | Institut Bergonie | Bordeaux | France | 33076 | |
| 139 | Centre Hospitalier Docteur Duchenne | Boulogne Sur Mer | France | 62200 | |
| 140 | Centre Regional Francois Baclesse | Caen | France | 14076 | |
| 141 | Centre Hospitalier Universitaire Henri Mondor | Creteil | France | 94010 | |
| 142 | Centre de Lutte Contre le Cancer, Georges-Francois Leclerc | Dijon | France | 21079 | |
| 143 | CHU de Grenoble - Hopital de la Tronche | Grenoble | France | 38043 | |
| 144 | Centre Hospitalier Departemental | La Roche Sur Yon | France | F-85025 | |
| 145 | Centre Oscar Lambret | Lille | France | 59020 | |
| 146 | Centre Leon Berard | Lyon | France | 69373 | |
| 147 | CHU de la Timone | Marseille | France | 13385 | |
| 148 | Hopital Lapeyronie-CHU Montpellier | Montpellier | France | 34295 | |
| 149 | Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | France | 34298 | |
| 150 | Centre Regional Rene Gauducheau | Nantes-Saint Herblain | France | 44805 | |
| 151 | Hopital Europeen Georges Pompidou | Paris | France | 75015 | |
| 152 | Institut Curie - Section Medicale | Paris | France | 75248 | |
| 153 | Hopital Tenon | Paris | France | 75970 | |
| 154 | Centre Eugene Marquis | Rennes | France | 35042 | |
| 155 | Centre Henri Becquerel | Rouen | France | 76038 | |
| 156 | Centre Rene Huguenin | Saint Cloud | France | 92211 | |
| 157 | Centre Medico-Chirurgical Foch | Suresnes | France | 92151 | |
| 158 | Centre Antoine Lacassagne | Toulouse | France | 31052 | |
| 159 | Institut Claudius Regaud | Toulouse | France | 31052 | |
| 160 | Centre Alexis Vautrin | Vandoeuvre-les-Nancy | France | 54511 | |
| 161 | Krankenhaus Hohe Warte Mediziniche Klinik | Bayreuth | Germany | 95445 | |
| 162 | Charite Humboldt - University Berlin | Berlin | Germany | D-10117 | |
| 163 | Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin | Berlin | Germany | D-12200 | |
| 164 | Helios - Klinik Blankenhain | Blankenhain | Germany | 99444 | |
| 165 | Universitaetsklinikum Bonn | Bonn | Germany | D-53105 | |
| 166 | Staedtische Kliniken Dortmund | Dortmund | Germany | 44143 | |
| 167 | Universitaetsklinik Duesseldorf | Duesseldorf | Germany | D-40225 | |
| 168 | St. Markus Krankenhaus | Frankfurt | Germany | 60431 | |
| 169 | Klinikum der J.W. Goethe Universitaet | Frankfurt | Germany | D-60590 | |
| 170 | Klinikum Fulda | Fulda | Germany | D-36013 | |
| 171 | Martin Luther Universitaet | Halle | Germany | D-06097 | |
| 172 | Marienkrankenhaus | Hamburg | Germany | 22087 | |
| 173 | Universitat des Saarlandes Innere Medizin 1 | Hamburg | Germany | D-66421 | |
| 174 | Klinikum der Friedrich-Schiller Universitaet Jena | Jena | Germany | D-07740 | |
| 175 | Klinikum der Stadt Ludwigshafen am Rhein | Ludwigshafen am Rhein | Germany | D-67063 | |
| 176 | Staedtisches Krankenhaus Sued | Luebeck | Germany | 23560 | |
| 177 | Medizinische Universitaet Luebeck | Luebeck | Germany | D-23538 | |
| 178 | Kreiskrankenhaus Luedenscheid | Luedenscheid | Germany | 58515 | |
| 179 | Klinikum der Stadt Mannheim | Mannheim | Germany | D-68135 | |
| 180 | University of Marburg | Marburg | Germany | D-35033 | |
| 181 | Klinik und Poliklinik fuer Kinderheilkunde | Muenster | Germany | D-48129 | |
| 182 | Klinikum Rechts Der Isar - Technische Universitaet Muenchen | Munich | Germany | D-81675 | |
| 183 | Klinikum Neubrandenburg | Neubrandenburg | Germany | 17036 | |
| 184 | Klinikum Nuernberg - Klinikum Nord | Nuernberg | Germany | D-90419 | |
| 185 | Paracelsus Karankenhaus Ruit | Ostfildern | Germany | 73760 | |
| 186 | Asklepios Klinik Pasewalk | Pasewalk | Germany | 17309 | |
| 187 | Diakonie - Krankenhaus | Rotenburg | Germany | DOH-27356 | |
| 188 | Johanniter Kankenhaus Stendal | Stendal | Germany | 39576 | |
| 189 | Katharinenhospital | Stuttgart | Germany | D-70174 | |
| 190 | Universitaetsklinikum Tuebingen | Tuebingen | Germany | D-72076 | |
| 191 | Universitaet Ulm | Ulm | Germany | D-89075 | |
| 192 | Klinikum der Stadt Wolfsburg | Wolfsburg | Germany | D-38440 | |
| 193 | Klinikum St. Marien | Wuppertal | Germany | D-42283 | |
| 194 | Witten University - Klinikum Wuppertal | Wuppertal | Germany | D-42283 | |
| 195 | National Institute of Oncology | Budapest | Hungary | 1125 | |
| 196 | Rabin Medical Center - Beilinson Campus | Petah-Tikva | Israel | 49100 | |
| 197 | Assaf Harofeh Medical Center | Zerifin | Israel | 70300 | |
| 198 | Ospedale Santa Croce | Cuneo | Italy | 12100 | |
| 199 | Istituto Scientifico H.San Raffaele | Milano | Italy | 20132 | |
| 200 | Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | Amsterdam | Netherlands | 1066 CX | |
| 201 | Jeroen Bosch Ziekenhuis | NL'S Hertogenbosch | Netherlands | NL-5211 | |
| 202 | Daniel Den Hoed Cancer Center at Erasmus Medical Center | Rotterdam | Netherlands | 3008 AE | |
| 203 | Academisch Ziekenhuis Utrecht | Utrecht | Netherlands | 3584 CX | |
| 204 | University Hospital - Rotterdam Dijkzigt | Utrecht | Netherlands | 3584 CX | |
| 205 | Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | Warsaw | Poland | 02-781 | |
| 206 | National Cancer Institute - Bratislava | Bratislava | Slovakia | 833 10 | |
| 207 | Hospital Universitari Germans Trias i Pujol | Badalona | Spain | 08916 | |
| 208 | Hospital Del Mar | Barcelona | Spain | 08003 | |
| 209 | Hospital Clinic y Provincial de Barcelona | Barcelona | Spain | 08036 | |
| 210 | Hospital General Universitari Vall d'Hebron | Barcelona | Spain | 08036 | |
| 211 | Hospital Juan Canalejo | Coruna | Spain | 15006 | |
| 212 | Hospital General Universitario De Guadalajara | Guadalajara | Spain | 19002 | |
| 213 | Hospital Cuidad de Jaen | Jaen | Spain | E-23006 | |
| 214 | Hospital Arquitecto Marcide | La Coruna | Spain | 15405 | |
| 215 | Hospital Universitario San Carlos | Madrid | Spain | 28040 | |
| 216 | Hospital Universitario 12 de Octubre | Madrid | Spain | 28041 | |
| 217 | Hospital Clinico Universitario - Malaga | Malaga | Spain | 29010 | |
| 218 | Hospital Son Dureta | Palma De Mallorca | Spain | 07014 | |
| 219 | Hospsital de Sabadell | Sabadell | Spain | 08208 | |
| 220 | Hospital Universitario Marques de Valdecilla | Santander | Spain | 39008 | |
| 221 | Hospital Consorci Sanitari De Terrassa | Terrassa | Spain | 08227 | |
| 222 | Instituto Valenciano De Oncologia | Valencia | Spain | 46009 | |
| 223 | Hospital Clinico Universitario de Valencia | Valencia | Spain | 46010 | |
| 224 | Hospital Rio Hortega | Valladolid | Spain | 47010 | |
| 225 | Hospital General De Vic | Vic | Spain | 08500 | |
| 226 | Hospital Clinico Universitario | Zaragoza | Spain | 50009 | |
| 227 | Princess Royal Hospital | Hull | England | United Kingdom | HU8 9HE |
| 228 | St. James's University Hospital | Leeds | England | United Kingdom | LS9 7TF |
| 229 | Saint Bartholomew's Hospital | London | England | United Kingdom | EC1A 7BE |
| 230 | Guy's and St. Thomas' Hospitals NHS Trust | London | England | United Kingdom | SE1 9RT |
| 231 | Northern Centre for Cancer Treatment at Newcastle General Hospital | Newcastle Upon Tyne | England | United Kingdom | NE4 6BE |
| 232 | Royal South Hants Hospital | Southampton | England | United Kingdom | SO14 0YG |
| 233 | Royal Marsden Hospital - Sutton | Sutton | England | United Kingdom | SM2 5PT |
| 234 | Velindre Cancer Center at Velinde Hospital | Cardiff | Wales | United Kingdom | CF14 2TL |
Sponsors and Collaborators
- European Organisation for Research and Treatment of Cancer - EORTC
- National Cancer Institute (NCI)
- Groupe D'Etude des Tumeurs Uro-Genitales
- Institute of Cancer Research, United Kingdom
- Central European Cooperative Oncology Group
- NCIC Clinical Trials Group
- Southwest Oncology Group
- German Association of Urologic Oncology
- Spanish Oncology Genito-Urinary Group
- Medical Research Council
Investigators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00022191
Other Study ID Numbers:
- EORTC-30987
- EORTC-30987
- CAN-NCIC-BL7
- CECOG-EORTC-30987
- GAUO-EORTC-30987
- GETUG-EORTC-30987
- SOGUG-EORTC-30987
- SWOG-30987
- NCRI-CRUK-BA11
- MRC-BA11
First Posted:
Jan 27, 2003
Last Update Posted:
Jun 12, 2013
Last Verified:
Jun 1, 2013
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC
Additional relevant MeSH terms: