Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer

Launched by EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER - EORTC · Jan 26, 2003

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility 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