|
BCG With or Without Mitomycin in Treating Patients With Bladder Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on BCG With or Without Mitomycin in Treating Patients With Bladder Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. BCG With or Without Mitomycin in Treating Patients With Bladder Cancer Clinical research trials and BCG With or Without Mitomycin in Treating Patients With Bladder Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including BCG With or Without Mitomycin in Treating Patients With Bladder Cancer. BCG With or Without Mitomycin in Treating Patients With Bladder Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a BCG With or Without Mitomycin in Treating Patients With Bladder Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their BCG With or Without Mitomycin in Treating Patients With Bladder Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > BCG With or Without Mitomycin in Treating Patients With Bladder Cancer  BCG With or Without Mitomycin in Treating Patients With Bladder Cancer
BCG With or Without Mitomycin in Treating Patients With Bladder Cancer
For Condition: stage 0 bladder cancer,transitional cell carcinoma of the bladder,recurrent bladder cancer
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 tumor cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with biological therapy may kill more tumor cells. It is not yet known if BCG is more effective with or without mitomycin. PURPOSE: Randomizedphase II trial to compare the effectiveness of BCG plus mitomycin with that of BCG alone in treating patients who have bladder cancer.
Details: OBJECTIVES: - Compare the complete response rate of patients with carcinoma in situ of the bladder treated with adjuvant intravesical BCG with or without intravesical mitomycin following transurethral resection. - Compare the disease-free interval and type of recurrence after complete response in patients treated with these regimens. - Compare the side effects of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of two treatment arms. Arm I: - Induction therapy: Patients receive intravesical mitomycin over 1 hour once weekly on weeks 1-6 and intravesical BCG once weekly on weeks 7-12. Patients with visible lesions or disease recurrence or progression undergo transurethral resection (TUR) during weeks 16-18 and receive one additional course of intravesical therapy. - Maintenance therapy:Patients with a complete response after either course of induction therapy proceed to maintenance therapy comprising intravesical mitomycin once on week 1 and intravesical BCG once weekly on weeks 2 and 3. Maintenance therapy repeats every 6 months through year 3. Arm II: - Induction therapy:Patients receive intravesical BCG once weekly on weeks 1-6 and 10-12. Patients with visible lesions or disease recurrence or progression undergo transurethral resection (TUR) during weeks 16-18 and receive one additional course of intravesical therapy. - Maintenance therapy: Patients with a complete response after either course of induction therapy receive maintenance therapy comprising intravesical BCG once weekly on weeks 1-3. Maintenance therapy repeats every 6 months through year 3. Patients are followed every 6 months for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 84-126 patients (42-63 per treatment arm) will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed carcinoma in situ (CIS) of the bladder with urinary cytology - Primary CIS (no prior history of CIS, papillary, or solid transitional cell carcinoma [TCC] of the bladder and no concurrent papillary or solid TCC) OR - Secondary CIS (detected after complete resection of superficial Ta/T1 TCC of the bladder) OR - Concurrent CIS (in the presence of superficial primary or recurrent Ta/T1 TCC of the bladder) - No more than 28 days since prior transurethral resection (TUR) of all visible lesions - No muscle involvement - No prior or concurrent upper urinary tract tumors - No urethral strictures that would prevent endoscopic procedures and repeated catheterization - No upper urinary tract disease (e.g., vesico-ureteral reflux or massive stones) that would make multiple transurethral procedures risky PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant or nursing - No active tuberculosis (highly positive skin tests allowed if no active disease) - No disease that would preclude general anesthesia - No active intractable or uncontrollable infection - No other prior or concurrent malignancy except cured basal cell skin cancer - No psychological, familial, sociological, or geographical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior BCG Chemotherapy: - More than 3 months since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to the pelvis Surgery: - See Disease Characteristics Other: - More than 3 months since prior intravesical cytostatic agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AldoBono, , Ospedale di Circolo e Fondazione Macchi
Virga Jesse Hospital *Recruiting*
Hasselt, , 3500
Belgium
Recruiting Contact Person 32-309-990
Hospital Desterro *Recruiting*
Amadora, , P-2700
Portugal
Recruiting Contact Person 351-474-9564
Ospedale di Circolo e Fondazione Macchi *Recruiting*
Varese, , 21100
Italy
Recruiting Contact Person 39-278-111
Universita Degli Studi Di Pisa *Recruiting*
Pisa, , 56126
Italy
Recruiting Contact Person 39-59-2701
Onze Lieve Vrouw Ziekenhuis Aalst *Recruiting*
Aalst, , B-9300
Belgium
Recruiting Contact Person 32-785-353
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31-361-1111
University of Wales College of Medicine *Recruiting*
Cardiff, Wales, CF14 4XN
United Kingdom
Recruiting Contact Person 44-2074-7747
Academisch Ziekenhuis Maastricht *Recruiting*
Maastricht, , 6202 AZ
Netherlands
Recruiting Contact Person 31-387-6543
Universitair Ziekenhuis Gent *Recruiting*
Ghent, , B-9000
Belgium
Recruiting Contact Person 32-240-2011
Azienda Ospedaliera Maggiore Della Carita *Recruiting*
Novara, , 28100
Italy
Recruiting Contact Person 39-0321-373-3282
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-463-9222
Dokuz Eylul University School of Medicine *Recruiting*
Izmir, , 35340
Turkey
Recruiting Contact Person 90-259-8773
AZ Groeninge - Campus St. Maarten *Recruiting*
Kortrijk, , 8500
Belgium
Recruiting Contact Person 32-366-111
Pontefract General Infirmary *Recruiting*
West Yorks, England, WF8 1PL
United Kingdom
Recruiting Contact Person 44-600-600
Additional Information:
Study ID Numbers: CDR0000068869; UKCCCR-EORTC-30993,SEUG-EORTC-30993,FINNBLADDER-EORTC-30993,NCRI-EORTC-30993,GAUO-EORTC-30993,AURO-EORTC-30993,EORTC-30993
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023842
Other Transitional Cell Carcinoma Of The Bladder Studies:
1. Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
2. AD 32 Alone or With BCG Following Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer
3. Suramin in Treating Patients With Recurrent Bladder Cancer
4. Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer
5. Keyhole Limpet Hemocyanin Compared With Doxorubicin in Treating Patients With Bladder Cancer
Related Studies:
Other transitional cell carcinoma of the bladder Clinical Trials
Other Clinical Trials
Other Kortrijk Clinical Trials
BCG With or Without Mitomycin in Treating Patients With Bladder Cancer
|
|
|
|
|
|
|
|
