Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer

Phase 3TerminatedNCT00042887

European Organisation for Research and Treatment of Cancer - EORTC58 enrolled

Overview

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: 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Bladder Cancer

Interventions

mitomycin CDRUG

conventional surgeryPROCEDURE

Eligibility

Sex: ALLMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (12)

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Virga Jesse Hospital

Hasselt, Belgium

Data from ClinicalTrials.gov

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