Title
Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer
Chemoresection With 4 Weekly Intravesical Instillations Of Mitomycin C Versus Transurethral Resection (TUR) Followed By One Single Immediate Instillation Of Mitomycin C In Single, Small, Papillary Stage Ta, T1 Bladder Tumors: A Prospective Randomized Phase III Trial
Phase
Phase 3Study Type
InterventionalStatus
TerminatedIndication/Condition
Bladder CancerIntervention/Treatment
mitomycin ...Study Participants
58RATIONALE: 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: Randomized phase III trial to compare the effectiveness of chemotherapy alone with that of transurethral resection followed by chemotherapy in treating patients who have bladder cancer.
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.
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
