Chemotherapy With or Without Surgery in Treating Patients With Bladder Cancer

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase

Terminated

Phase 3

Conditions

Bladder Cancer

Treatments

Drug: mitomycin C

Procedure: conventional surgery

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00042887

EORTC-30004

Details and patient eligibility

About

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.

Full description

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.

Enrollment

58 patients

Sex

All

Ages

Under 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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