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.

Condition	Treatment or Intervention	Phase
stage 0 bladder cancer stage I bladder cancer recurrent bladder cancer transitional cell carcinoma of the bladder	Drug: mitomycin  Procedure: bladder irrigation  Procedure: chemotherapy  Procedure: conventional surgery  Procedure: surgery	Phase III

Further Study 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.

Ages Eligible for Study:  up to  80 Years,  Genders Eligible for Study:  Both

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

Belgium
      Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels,  1090,  Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium
      Universitair Ziekenhuis Gent, Ghent,  B-9000,  Belgium
      Virga Jesse Hospital, Hasselt,  3500,  Belgium
Italy
      Ospedale S.S. Annunziata, Savigliano,  12038,  Italy
      Universita Di Palermo, Palermo,  90141,  Italy
Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands
      Daniel Den Hoed Cancer Center at Erasmus Medical Center, Rotterdam,  3008 AE,  Netherlands
      Jeroen Bosch Ziekenhuis, NL'S Hertogenbosch,  NL-5211,  Netherlands
      Onze Lieve Vrouwe Gasthuis, Amsterdam,  1091 HA,  Netherlands
Slovakia
      Comenius University School of Medicine, Martin,  03659,  Slovakia
Turkey
      Dokuz Eylul University School of Medicine, Izmir,  35340,  Turkey

Study chairs or principal investigators

Willem Oosterlinck, MD, PhD,  Universitair Ziekenhuis Gent   

Study ID Numbers:  CDR0000069482; EORTC-30004
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  August 5, 2002
ClinicalTrials.gov Identifier:  NCT00042887
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08