Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Mitomycin; Mitomycins

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