Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	any age		MRC-BS03 EU-94007

Objectives

I.  Assess the recurrence rate of superficial transitional cell carcinoma of 
the bladder treated immediately following transurethral resection of tumor 
with intravesical instillation of mitomycin (MITO) vs. no adjuvant MITO.

II.  Assess the recurrence rate associated with single vs. multiple 
instillations of MITO at follow-up cystoscopy during the first year 
post-surgery.

III.  Assess the effect of urothelial atypism or carcinoma in situ found in 
random biopsies on the recurrence rate of superficial bladder cancer.

Entry Criteria

Disease Characteristics:

Histologically confirmed superficial (Ta/T1) transitional cell
carcinoma of the bladder eligible for complete endoscopic
resection

Disease limited to the bladder
  No evidence of carcinoma in the upper tracts on IVU
  No evidence of carcinoma in the urethra on urethroscopy

Prior/Concurrent Therapy:

No prior therapy

Patient Characteristics:

Age:
  Any age

Performance status:
  WHO 0-2

Life expectancy:
  At least 3 years

Hematopoietic:
  WBC greater than 3,000
  Platelets greater than 100,000

Hepatic:
  Not specified

Renal:
  No untreated urinary tract infection

Other:
  No history of other malignant tumors except nonmelanomatous
  skin cancer

Expected Enrollment

400 patients will be entered to accrue 330 evaluable patients.  As of 2/87, 
the study is closed.

Outline

All patients are treated on Regimen A, then randomized to Arms I, II, and III.

Regimen A:  Surgery.  Transurethral resection.

Arm I:  Single-Agent Chemotherapy.  Mitomycin, MITO, NSC-26980.  Single 
intravesical instillation.

Arm II:  Single-Agent Chemotherapy.  MITO.  Repeated intravesical 
instillations.

Arm III:  Control.  No further therapy.

Tolley DA, Parmar MK, Grigor KM, et al.: The effect of intravesical mitomycin C on recurrence of newly diagnosed superficial bladder cancer: a further report with 7 years of follow up. J Urol 155 (4): 1233-8, 1996.[PUBMED Abstract]

Tolley DA, Hargreave TB, Smith PH, et al.: Effect of intravesical mitomycin C on recurrence of newly diagnosed superficial bladder cancer: interim report from the Medical Research Council Subgroup on Superficial Bladder Cancer (Urological Cancer Working Party). Br Med J (Clin Res Ed) 296 (6639): 1759-61, 1988.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

Peter Fayers, MD, Protocol chair		Ph: 44-20-7670-4700