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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	no age specified		MRC-BS07 EU-94028

Objectives

I.  Compare time to recurrence in patients with superficial bladder cancer 
(Stage 0/I) randomized to a single intravesical instillation of epirubicin 
(EPI) vs. mitomycin (MITO) administered at equal doses following transurethral 
resection (TUR).

II.  Compare the recurrence rate in patients with superficial bladder cancer 
randomized to high-dose (80 mg) vs. standard dose (40 mg) EPI or MITO 
following TUR.

Entry Criteria

Disease Characteristics:

Histologically confirmed transitional cell carcinoma that is limited to the
bladder (pTa or pT1)
  No evidence of carcinoma in the upper urothelial tracts on intravenous
  urogram (IVU) or urethra on urethroscopy
     Current IVU (or other imaging) of the upper tracts required for tumors
     near ureteric orifice (IVU within previous 12 months acceptable for other
     disease sites)

  Histologic confirmation at initial presentation and at first recurrence
  required

Disease in first recurrence or first diagnosis of multiple tumors and
considered suitable for complete endoscopic resection
  Prior removal of initial tumor by complete transurethral resection (with or
  without postoperative irrigation) required

Patients previously entered into protocol MRC-BS04 (Study of Irrigation and
Chemotherapy in Superficial Bladder Cancer) who have not yet developed a first
recurrence are eligible for randomization on this study

Prior/Concurrent Therapy:

No prior intravesical chemotherapy

Patient Characteristics:

Age:
  Not specified

Performance status:
  WHO 0-2

Life expectancy:
  At least 3 years

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No untreated urinary tract infection
  No history of a second malignancy except:
     Nonmelanomatous skin tumors
     Cervical intra-epithelial neoplasia

Expected Enrollment

A total of 800 patients will be randomized.

Outline

Randomized study.  Patients are treated on Regimen A, then randomized to 
Groups I, II, III, or IV.

Regimen A:  Surgery.  Transurethral resection, TUR.

Group I:  Single-Agent Intravesical Chemotherapy.  Mitomycin, MITO, NSC-26980. 
 Standard dose.

Group II:  Single-Agent Intravesical Chemotherapy.  MITO.  High dose.

Group III:  Single-Agent Intravesical Chemotherapy.  Epirubicin, EPI, 
NSC-256942.  Standard dose.

Group IV:  Single-Agent Intravesical Chemotherapy.  EPI.  High dose.

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

David M.A. Wallace, MB, BS, FRCS, Protocol chair		Ph: 44-121-472-1311