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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 Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on 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 conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like 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. 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 Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a 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 clinical trial. Human subjects often obtain the finest healthcare possible for their 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 condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.

Home > "C" Clinical Trials Conditions > 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

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



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

For Condition: stage 4 bladder cancer,transitional cell carcinoma of the bladder,stage 3 bladder cancer
Status: Recruiting
Sponsor(s): EORTC Genito-Urinary Tract Cancer Cooperative Group , Groupe D'Etude des Tumeurs Uro-Genitales,Southwest Oncology Group,Nordic Urothelial Cancer Group,National Cancer Institute of Canada,National Cancer Research Institute (NCRI),American College of Surgeons
Synopsis: RATIONALE: 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. PURPOSE: Randomizedphase 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 bladderurothelium.
Details: OBJECTIVES: - 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. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, tumor status (pT1 or 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 and cisplatin comprising 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. PROJECTED ACCRUAL: A total of 1,344 patients (672 per treatment arm) will be accrued for this study within 5.37 years.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol 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 PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - WHO 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,500/mm^3 - Platelet count at least 120,000/mm^3 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 (T1, 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
IanTannock,  Study Chair,  Princess Margaret Hospital

James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester,  New York,  14642
United States
Recruiting Richard  Fisher 585-275-0842

Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto,  Ontario,  M4N 3M5
Canada
Recruiting Contact  Person 416-480-5000

British Columbia Cancer Agency - Centre for the Southern Interior *Recruiting*
Kelowna,  British Columbia,  V1Y 5L3
Canada
Recruiting Contact  Person 250-712-3900

University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor,  Michigan,  48109-0330
United States
Recruiting Cheryl  Lee 734-615-6662

Royal South Hants Hospital *Recruiting*
Southampton,  England,  SO14 0YD
United Kingdom
Recruiting Contact  Person 44-23-8077-7222

Centre Hospitalier General de Saint Nazaire *Recruiting*
Saint-Nazaire,  ,  44600
France
Recruiting Contact  Person 33-2-4090-6000

Institut Jules Bordet *Recruiting*
Brussels,  ,  1000
Belgium
Recruiting Contact  Person 32-2-541-3111

Kingston Regional Cancer Centre *Recruiting*
Kingston,  Ontario,  K7L 5P9
Canada
Recruiting Contact  Person 613-544-2630

Cross Cancer Institute *Recruiting*
Edmonton,  Alberta,  T6G 1Z2
Canada
Recruiting Contact  Person 780-432-8771

Ottawa Regional Cancer Centre *Recruiting*
Ottawa,  Ontario,  K1H 1C4
Canada
Recruiting Contact  Person 613-725-6300

Hopitaux Universitaire de Strasbourg *Recruiting*
Strasbourg,  ,  67091
France
Recruiting Contact  Person 33-3-8811-6768

Klinikum Nuernberg - Klinikum Nord *Recruiting*
Nuernberg,  ,  D-90419
Germany
Recruiting Contact  Person 49-911-398-2460

Centre Regional Francois Baclesse *Recruiting*
Caen,  ,  14076
France
Recruiting Contact  Person 33-2-3145-5000

British Columbia Cancer Agency *Recruiting*
Vancouver,  British Columbia,  V5Z 4E6
Canada
Recruiting Contact  Person 604-877-6000

Princess Margaret Hospital *Recruiting*
Toronto,  Ontario,  M5G 2M9
Canada
Recruiting Contact  Person 416-946-2000

Institut Bergonie *Recruiting*
Bordeaux,  ,  33076
France
Recruiting Contact  Person 33-5-5633-3333

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology *Recruiting*
Warsaw,  ,  02-781
Poland
Recruiting Contact  Person 48-22-546-2169

Fletcher Allen Health Care - University Health Center Campus *Recruiting*
Burlington,  Vermont,  05401
United States
Recruiting Steven  Grunberg 802-847-8400

Ospedale S. Camillo-Forlanini *Recruiting*
Rome,  ,  00151
Italy
Recruiting Contact  Person 39-5-870-2870

Veterans Affairs Medical Center - Amarillo *Recruiting*
Amarillo,  Texas,  79106
United States
Recruiting William  Robinson 806-355-9703

British Columbia Cancer Agency - Vancouver Island Cancer Centre *Recruiting*
Victoria,  British Columbia,  V8R 6V5
Canada
Recruiting Contact  Person 250-519-5500

Montreal General Hospital *Recruiting*
Montreal,  Quebec,  H3G 1A4
Canada
Recruiting Armen  Aprikian 514-934-8295

Onze Lieve Vrouw Ziekenhuis Aalst *Recruiting*
Aalst,  ,  B-9300
Belgium
Recruiting Contact  Person 32-53-78-5353

U.Z. Gasthuisberg *Recruiting*
Leuven,  ,  B-3000
Belgium
Recruiting Contact  Person 32-16-33-2211

MBCCOP - Massey Cancer Center *Recruiting*
Richmond,  Virginia,  23298-0037
United States
Recruiting John  Roberts 804-828-0450

Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi,  Mississippi,  39531-2410
United States
Recruiting Robert  Veith 504-568-5151

Centre Paul Papin *Recruiting*
Angers,  ,  49036
France
Recruiting Contact  Person 33-2-4135-2700

Institut Gustave Roussy *Recruiting*
Villejuif,  ,  F-94805
France
Recruiting Contact  Person 33-1-4211-4211

Kaiser Franz Josef Hospital *Recruiting*
Vienna,  ,  A-1100
Austria
Recruiting Contact  Person 43-1-601-9152

University Hospital - Rotterdam Dijkzigt *Recruiting*
Rotterdam,  ,  3000 CA
Netherlands
Recruiting Contact  Person 31-10-463-9222

Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston,  South Carolina,  29425
United States
Recruiting Carolyn  Reed 843-792-3362

Harrington Cancer Center *Recruiting*
Amarillo,  Texas,  79106
United States
Recruiting James  Clarkson 806-359-4673

Nova Scotia Cancer Centre *Recruiting*
Halifax,  Nova Scotia,  B3H 1V7
Canada
Recruiting Contact  Person 902-473-6000

Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Thomas  Lad 312-996-2046

Norwegian Radium Hospital *Recruiting*
Oslo,  ,  N-0310
Norway
Recruiting Contact  Person 47-22-93-4000

St. James's University Hospital *Recruiting*
Leeds,  England,  LS9 7TF
United Kingdom
Recruiting Contact  Person 44-113-206-4904

Universita di Palermo *Recruiting*
Palermo,  ,  90141
Italy
Recruiting Contact  Person 39-91-625-5292

Centre de Lutte Contre le Cancer, Georges-Francois Leclerc *Recruiting*
Dijon,  ,  21079
France
Recruiting Contact  Person 33-3-8073-7500

McGill University *Recruiting*
Montreal,  Quebec,  H2W 1S6
Canada
Recruiting Contact  Person 514-398-1444

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle *Recruiting*
Montpellier,  ,  34298
France
Recruiting Contact  Person 33-4-6761-3100

CHU Liege - Domaine Universitaire du Sart Tilman *Recruiting*
LIEGE,  ,  B-4000
Belgium
Recruiting Contact  Person 32-42-366-7111

Centre Medico-Chirurgical Foch *Recruiting*
Suresnes,  ,  92151
France
Recruiting Contact  Person 33-1-4772-9191

Akademisch Ziekenhuis Gent *Recruiting*
Gent,  ,  B-9000
Belgium
Recruiting Contact  Person 32-92-240-2011

Centre Hospitalier Departemental *Recruiting*
La Roche-sur-Yon,  ,  F-85025
France
Recruiting Contact  Person 33-2-5144-6112

University Medical Center Nijmegen *Recruiting*
Nijmegen,  ,  NL-6500 HB
Netherlands
Recruiting Contact  Person 31-24-361-1111

Uppsala University Hospital *Recruiting*
Uppsala,  ,  SE-75185
Sweden
Recruiting Per-Uno  Malmstrom 18-611-0000

Guy's and St. Thomas' Hospitals NHS Trust *Recruiting*
London,  England,  SE1 9RT
United Kingdom
Recruiting Contact  Person 44-20-7928-9292

Northern Centre for Cancer Treatment at Newcastle General Hospital *Recruiting*
Newcastle upon Tyne,  England,  NE4 6BE
United Kingdom
Recruiting Contact  Person 44-191-273-8811

Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton,  Ontario,  L8V 5C2
Canada
Recruiting Contact  Person 905-387-9495

Veterans Affairs Medical Center - Albany *Recruiting*
Albany,  New York,  12208
United States
Recruiting James  Holland 518-462-3311 ext. 2328

Ospedale di Circolo e Fondazione Macchi *Recruiting*
Varese,  ,  21100
Italy
Recruiting Contact  Person 39-332-278-111

Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City,  Kansas,  66160-7390
United States
Recruiting James  Thrasher 913-588-6152

Centre Leon Berard *Recruiting*
Lyon,  ,  69373
France
Recruiting Contact  Person 33-4-7878-2828

Institut Claudius Regaud *Recruiting*
Toulouse,  ,  31052
France
Recruiting Contact  Person 33-5-6142-4242

Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City,  New York,  10032
United States
Recruiting Mitchell  Benson 212-305-5201

Institut J. Paoli and I. Calmettes *Recruiting*
Rennes,  ,  35042
France
Recruiting Contact  Person 33-4-9122-3333

Fraser Valley Cancer Centre at British Columbia Cancer Agency *Recruiting*
Surrey,  British Columbia,  V3V 1Z2
Canada
Recruiting Contact  Person 604-930-4060

Centre Regional Rene Gauducheau *Recruiting*
Nantes-Saint Herblain,  ,  44805
France
Recruiting Contact  Person 33-2-4067-9900

Tom Baker Cancer Center - Calgary *Recruiting*
Calgary,  Alberta,  T2N 4N2
Canada
Recruiting Contact  Person 403-270-1700

Marmara University Hospital *Recruiting*
Istanbul,  ,  81190
Turkey
Recruiting Contact  Person 90-216-327-5050

Hopital Notre- Dame du CHUM *Recruiting*
Montreal,  Quebec,  H4L 2M1
Canada
Recruiting Contact  Person 514-890-8000

Danville Radiation Therapy Center *Recruiting*
Memphis,  Tennessee,  38104
United States
Recruiting Mohammad  Jahanzeb 901-523-8990

Addenbrooke's NHS Trust *Recruiting*
Cambridge,  England,  CB2 2QQ
United Kingdom
Recruiting Contact  Person 44-1223-24-5151

Veterans Affairs Medical Center - Charleston *Recruiting*
Charleston,  South Carolina,  29401-5799
United States
Recruiting Andrew  Turrisi 843-792-273

CancerCare Manitoba *Recruiting*
Winnipeg,  Manitoba,  R3E 0V9
Canada
Recruiting Contact  Person 204-787-2241

Guy's Hospital *Recruiting*
London,  England,  SE1 9RT
United Kingdom
Recruiting Contact  Person 44-20-7955-5000

Cliniques Universitaires Saint-Luc *Recruiting*
Brussels,  ,  1200
Belgium
Recruiting Contact  Person 32-2-764-1111

Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London,  Ontario,  N6A 4L6
Canada
Recruiting Contact  Person 519-685-8600

Veterans Affairs Medical Center - Houston *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Gauri  Varadhachary 713-791-1414 ext. 5340

AZ Groeninge - Campus St. Maarten *Recruiting*
Kortrijk,  ,  8500
Belgium
Recruiting Contact  Person 32-56-366-111

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital *Recruiting*
Amsterdam,  ,  1066 CX
Netherlands
Recruiting Contact  Person 31-20-512-9111

MBCCOP - Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Brian  Issell 808-586-3013

Centre Alexis Vautrin *Recruiting*
Vandoeuvre-les-Nancy,  ,  54511
France
Recruiting Contact  Person 33-3-8359-8400

Centre Oscar Lambret *Recruiting*
Lille,  ,  59020
France
Recruiting Contact  Person 33-3-2029-5959

Centre Eugene Marquis *Recruiting*
Rennes,  ,  35042
France
Recruiting Contact  Person 33-2-9925-3178

Universitaetsklinikum Bonn *Recruiting*
Bonn,  ,  D-53105
Germany
Recruiting Contact  Person 49-228-280-3816

University of Tennessee Cancer Institute *Recruiting*
Memphis,  Tennessee,  38103
United States
Recruiting Mohammad  Jahanzeb 901-722-0532

Hotel Dieu Health Sciences Hospital - Niagara *Recruiting*
St. Catharines,  Ontario,  L2R 5K3
Canada
Recruiting Contact  Person 905-682-6451


Additional Information:
Study ID Numbers:
  CDR0000069130;  JUG-EORTC-30994,SEUG-EORTC-30994,NORDIC-EORTC-30994,NCRI-BLADDER-EORTC-30994,EORTC-30994,ACOSOG-EORTC-30994,CAN-NCIC-EORTC-30994,UKCCCR-EORTC-30994,GETUG-EORTC-30994,SWOG-EORTC-30994
Study Start Date: 
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028756

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2. 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

3. Surgery and BCG in Treating Patients With Bladder Cancer

4. Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer

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