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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.
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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
Other Transitional Cell Carcinoma Of The Bladder Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer
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
5. Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer
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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
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