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Home > "C" Clinical Trials Conditions > Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer  Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
For Condition: recurrent bladder cancer,stage 1 bladder cancer,transitional cell carcinoma of the bladder,stage 0 bladder cancer
Status: Recruiting
Sponsor(s): EORTC Genito-Urinary Tract Cancer Cooperative Group ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing chemotherapy drugs directly into the bladder may kill more cancer cells. It is not yet known if surgery followed by chemotherapy is more effective than chemotherapy alone in treating bladder cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of chemotherapy alone with that of transurethral resection followed by chemotherapy in treating patients who have bladder cancer.
Details: OBJECTIVES: - Compare the efficacy of chemoresection with 4 weekly intravesical instillations of mitomycin vs transurethral resection followed by 1 instillation of mitomycin in patients with low-risk superficial transitional cell carcinoma of the bladder. - Compare the disease-free survival of patients treated with these regimens. - Determine the response rate at 6 weeks in patients treated with chemoresection. - Determine the percent of patients with tumor at 6 weeks treated with transurethral resection. - Compare the quality of life of patients treated with these regimens. - Compare the side effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (primary vs recurrent) and participating center. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo chemoresection with intravesical instillation of mitomycin once weekly for 4 weeks. - Arm II: Patients undergo transurethral resection followed within 1-6 hours by intravesical instillation of mitomycin. Quality of life is assessed at baseline, at week 1 (arm II only), at week 5 (arm I only), and then at week 6. Patients are followed at weeks 6 and 19, every 6 months for 3 years, and then annually for 2 years. PROJECTED ACCRUAL: A total of 1,000 patients (500 per treatment arm) will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Cytologically confirmed solitary primary or recurrent papillary transitional cell carcinoma of the bladder - Ta or T1 - Tumor no greater than 2 cm in diameter - Negative urine cytology - No suspicious lesions in bladder requiring biopsy - No tumors in the prostatic urethra or upper urinary tract - No prior history of T1 G3 tumors, muscle invasive tumors (T2 or greater), or carcinoma in situ PATIENT CHARACTERISTICS: Age - 80 and under Performance status - WHO 0-1 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - HIV negative - No active intractable or uncontrollable bladder infection - No urethral strictures that would preclude endoscopic procedures or repeated catheterization - No prior or concurrent congenital or acquired immune deficiency syndrome - No other prior or concurrent malignancy except cured basal cell skin cancer or intraepithelial cancer of the cervix - No prior or concurrent leukemia or Hodgkin's disease - No concurrent disease for which general anesthesia is contraindicated - No psychological, familial, sociological, or geographical condition that would preclude study compliance - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy - More than 12 months since prior BCG vaccine Chemotherapy - At least 1 year since prior mitomycin Endocrine therapy - Not specified Radiotherapy - No prior pelvic radiotherapy Surgery - No prior organ transplant Other - At least 3 months since prior intravesical treatment
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WillemOosterlinck, , Universitair Ziekenhuis Gent
Universita Di Palermo *Recruiting*
Palermo, , 90141
Italy
Recruiting Contact Person 39-91-625-5292
Comenius University School of Medicine *Recruiting*
Martin, , 03659
Slovakia
Recruiting Contact Person 421-413-3034
Ospedale S.S. Annunziata *Recruiting*
Savigliano, , 12038
Italy
Recruiting Contact Person 39-172-719-111
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting Contact Person 31-20-566-9111
Dokuz Eylul University School of Medicine *Recruiting*
Izmir, , 35340
Turkey
Recruiting Contact Person 90-232-259-8773
Jeroen Bosch Ziekenhuis *Recruiting*
NL'S Hertogenbosch, , NL-5211
Netherlands
Recruiting Contact Person 31-3173-616-2434
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-332-211
Onze Lieve Vrouwe Gasthuis *Recruiting*
Amsterdam, , 1091 HA
Netherlands
Recruiting Contact Person 31-20-599-9111
Academisch Ziekenhuis der Vrije Universiteit Brussel *Recruiting*
Brussels, , 1090
Belgium
Recruiting Contact Person 32-2-477-6040
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-10-463-9222
Universitair Ziekenhuis Gent *Recruiting*
Ghent, , B-9000
Belgium
Recruiting Contact Person 32-9-240-2011
Virga Jesse Hospital *Recruiting*
Hasselt, , 3500
Belgium
Recruiting Contact Person 32-11-309-990
Additional Information:
Study ID Numbers: CDR0000069482; EORTC-30004
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042887
Other Recurrent Bladder Cancer Studies:
1. Celecoxib in Treating Patients With Bladder Cancer
2. Oxaliplatin in Treating Patients With Metastatic Bladder Cancer
3. BCG With or Without Mitomycin in Treating Patients With Bladder Cancer
4. Docetaxel and Gemcitabine in Treating Patients With Progressive Regional or Metastatic Bladder Cancer
5. Tipifarnib in Treating Patients With Recurrent Bladder Cancer
Related Studies:
Other recurrent bladder cancer Clinical Trials
Other Clinical Trials
Other Ghent Clinical Trials
Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
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