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Home > "S" Clinical Trials Conditions > Surgery and BCG in Treating Patients With Bladder Cancer  Surgery and BCG in Treating Patients With Bladder Cancer
Surgery and BCG in Treating Patients With Bladder Cancer
For Condition: stage 0 bladder cancer,stage 1 bladder cancer,transitional cell carcinoma of the bladder
Status: Recruiting
Sponsor(s): EORTC Genito-Urinary Tract Cancer Cooperative Group ,
Synopsis: RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Randomizedphase III trial to compare the effectiveness of BCG at different dosages and lengths of time following surgery in treating patients with bladder cancer.
Details: OBJECTIVES: - Demonstrate that after complete transurethral resection of all papillary tumors, one third dose BCG (Bacillus Calmette-Guerin vaccine; OncoTICE) is equivalent to full dose BCG and short term maintenance is equivalent to long term maintenance with respect to duration of disease free interval, recurrence rate, percentage of patients with an increase in T-category to greater than T1, and the incidence of carcinoma in situ during follow-up. - Demonstrate that one third dose BCG and short term maintenance are associated with fewer local and systemic side effects. OUTLINE: This is a prospective randomized study. At 7-15 days after transurethral resection, patients will begin receiving one of the following four regimens: - Regimen 1: One third dose Bacillus Calmette-Guerin (BCG) vaccine plus short term maintenance. Patients receive a one third dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, and 12. - Regimen 2: Full dose BCG plus short term maintenance. Patients receive a full dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, and 12. - Regimen 3: One third dose BCG plus long term maintenance. Patients receive a one third dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, 12, 18, 24, 30 and 36. - Regimen 4: Full dose BCG plus long term maintenance. Patients receive a full dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations at months 3, 6, 12, 18, 24, 30, and 36. The patient is followed every 3 months for the first 3 years, and every 6 months thereafter. PROJECTED ACCRUAL: 1288 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /85 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed transitional cell carcinoma of the bladder of the following types: - Multiple (not greater than 10), resectable, T1 or Ta, grade G1-G3 - Solitary T1 GIII tumor PATIENT CHARACTERISTICS: Age: - 85 and under Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Values used to evaluate function may not exceed two times the upper limit of normal Renal: - Values used to evaluate function may not exceed two times the upper limit of normal Other: - No second malignancy except basal cell skin carcinoma - Not pregnant or nursing - No uncontrollable urinary tract infection - No active tuberculosis - No HIV antibody - No leukemia - No Hodgkin's disease - No transplant recipients PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior treatment with BCG Chemotherapy: - No cytostatic agents within the past 3 months Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
A.P.MDer Meijden, , Jeroen Bosch Ziekenhuis
Onze Lieve Vrouw Ziekenhuis Aalst *Recruiting*
Aalst, , B-9300
Belgium
Recruiting Contact Person 32-53-785-353
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31-24-361-1111
Academisch Ziekenhuis Maastricht *Recruiting*
Maastricht, , 6202 AZ
Netherlands
Recruiting Contact Person 31-43-387-6543
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-2-541-3111
Universitair Ziekenhuis Gent *Recruiting*
Ghent, , B-9000
Belgium
Recruiting Contact Person 32-92-240-2011
Universita Degli Studi Di Pisa *Recruiting*
Pisa, , 56126
Italy
Recruiting Contact Person 39-50-592-701
Hopital Edouard Herriot *Recruiting*
Lyon, , 69437
France
Recruiting Contact Person 33-4-7211-7300
Academisch Ziekenhuis Utrecht *Recruiting*
Utrecht, , 3584 CX
Netherlands
Recruiting Contact Person 31-30-250-9111
AZ Groeninge - Campus St. Maarten *Recruiting*
Kortrijk, , 8500
Belgium
Recruiting Contact Person 32-56-366-111
Virga Jesse Hospital *Recruiting*
Hasselt, , 3500
Belgium
Recruiting Contact Person 32-11-30-9990
Onze Lieve Vrouwe Gasthuis *Recruiting*
Amsterdam, , 1091 HA
Netherlands
Recruiting Contact Person 31-20-599-9111
G. Hatzikosta General Hospital *Recruiting*
Ioannina, , 45001
Greece
Recruiting Contact Person 30-21-80-549
Rabin Medical Center - Beilinson Campus *Recruiting*
Petah-Tikva, , 49100
Israel
Recruiting Contact Person 972-3-937-7377
Groot Ziekengasthuis 's-Hertogenbosch *Recruiting*
's-Hertogenbosch, , 5211 NL
Netherlands
Recruiting Contact Person 31-73-611-2446
Azienda Ospedaliera Maggiore Della Carita *Recruiting*
Novara, , 28100
Italy
Recruiting Contact Person 39-321-373-3282
Hopitaux Universitaire de Strasbourg *Recruiting*
Strasbourg, , 67091
France
Recruiting Contact Person 33-3-8811-6768
Dokuz Eylul University School of Medicine *Recruiting*
Izmir, , 35340
Turkey
Recruiting Contact Person 90-232-259-8773
Pontefract General Infirmary *Recruiting*
Pontefract West Yorkshire, England, WF8 1PL
United Kingdom
Recruiting Contact Person 44-1977-600-600
Azienda Ospedale S. Luigi - Universita Di Torino *Recruiting*
Orbassano, (Torino), , 10043
Italy
Recruiting Contact Person 39-9-026-511
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-71-52-6911
Ospedale di Circolo e Fondazione Macchi *Recruiting*
Varese, , 21100
Italy
Recruiting Contact Person 39-332-278-111
Marmara University Hospital *Recruiting*
Istanbul, , 81190
Turkey
Recruiting Contact Person 90-212-327-5050
Universita Di Palermo *Recruiting*
Palermo, , 90145
Italy
Recruiting Contact Person 39-91-625-5292
Istituto Scientifico H.San Raffaele *Recruiting*
Milano, , 20132
Italy
Recruiting Contact Person 39-2-643-2653
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting Contact Person 31-20-566-9111
Ospedale Molinette *Recruiting*
Turin, , 10126
Italy
Recruiting Contact Person 39-06-6566
Freeman Hospital *Recruiting*
Newcastle upon Tyne, England, NE7 7DN
United Kingdom
Recruiting Contact Person 44-191-284-3111
Rijnland Ziekenhuis *Recruiting*
Leiderdorp, , 2350 CC
Netherlands
Recruiting Contact Person 31-71-589-9250
University Hospital - Rotterdam Dijkzigt *Recruiting*
Rotterdam, , 3000 CA
Netherlands
Recruiting Contact Person 31-10-463-9222
Hospital Desterro *Recruiting*
Amadora, , P-2700
Portugal
Recruiting Contact Person 351-474-9564
University of Patras Medical School *Recruiting*
Rio Patras, , GR-26500
Greece
Recruiting Contact Person 30-61-997-550
St. James's University Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting Contact Person 44-113-206-4904
Ospedale Di Desio *Recruiting*
Milan, , 20033
Italy
Recruiting Contact Person 39-362-3831
Academisch Ziekenhuis der Vrije Universiteit Brussel *Recruiting*
Brussels, , 1090
Belgium
Recruiting Contact Person 32-2-477-6040
Gartnavel General Hospital *Recruiting*
Glasgow, Scotland, G12 0YN
United Kingdom
Recruiting Contact Person 44-141-211-3000
St. Franciscus Gasthuis *Recruiting*
Rotterdam, , 3045 PM
Netherlands
Recruiting Contact Person 31-10-42-2334
Amphia Ziekenhuis *Recruiting*
Breda, , 4810 EV
Netherlands
Recruiting Contact Person 31-76-527-7911
Cliniques Universitaires Saint-Luc *Recruiting*
Brussels, , 1200
Belgium
Recruiting Contact Person 32-2-764-1111
Celal Bayar University *Recruiting*
Manisa, , 45010
Turkey
Recruiting Contact Person 90-236-232-3133
Institute of Oncology - Bucarest *Recruiting*
Bucarest, , RO 72435
Romania
Recruiting Contact Person 40-21-240-8764
Kaiser Franz Josef Hospital *Recruiting*
Vienna, , A-1100
Austria
Recruiting Contact Person 43-1-601-9152
Additional Information:
Study ID Numbers: CDR0000065529; EORTC-30962
Study Start Date:
Record last reviewed: January 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002990
Other Stage 0 Bladder Cancer Studies:
1. Paclitaxel in Treating Patients With Early-Stage Bladder Cancer
2. Interleukin-2 Combined With Monoclonal Antibody Therapy in Treating Patients With Kidney, Bladder, or Lung Cancer That Has Not Responded to Previous Treatment
3. Combination Chemotherapy in Treating Patients With Advanced Bladder or Kidney Cancer
4. SCH 66336 Plus Gemcitabine in Treating Patients With Advanced Cancer of the Urinary Tract
5. R115777 in Treating Patients With Advanced Bladder Cancer
Related Studies:
Other stage 0 bladder cancer Clinical Trials
Other Clinical Trials
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Surgery and BCG in Treating Patients With Bladder Cancer
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