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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Closed	85 and under		EORTC-30864

Objectives

I.  Study the ablative or reductive activity of intravesical mitomycin-C on a 
papillary marker lesion in patients with multiple superficial tumors of the 
bladder.
II.  Study the prognostic value of the response of the marker lesion on the 
long-term recurrence or progression rate.
III.  Study the influence of a course of eight weekly instillations of 
mitomycin-C after transurethral resection on the recurrence rate, time to 
first recurrence, and the progression in T category or grade.
IV.  Compare the effect of this regimen alone with an additional long-term 
maintenance regimen (mitomycin-C every 2 months for 2 years) on the same 
parameters.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients no more than 85 years of age 
with multiple, primary and recurrent, resectable, histologically proven Ta-T1 
papillary transitional cell carcinoma of the bladder.  Patients with a 
solitary lesion or with carcinoma in situ or bladder cancer of a type other 
than transitional cell carcinoma are not eligible.  Prior treatment with 
either systemic or intravesical mitomycin-C excludes; prior treatment with 
intravesical drugs other than mitomycin-C is allowed provided at least 3 
months have elapsed before entry onto study.  Prior to registration, patients 
must undergo resection of all visible lesions except for one marker lesion not 
exceeding 1 cm in diameter and located in a well-defined area at least 1 cm 
from any resected area; in patients with tumors that all exceed 1 cm in 
largest diameter, the smallest lesion will be the marker lesion.  Except for 
the marker lesion, biopsies of all proliferative and suspect areas are 
required, as are random biopsies of normal mucosa adjacent to and at a 
distance from the tumor.  Each tumor site and biopsy site and location and 
size of the two largest perpendicular diameters of the marker lesion must be 
indicated on the bladder map.  Patients must have a bladder capacity of at 
least 150 ml, a life expectancy of at least 3 years, a performance status of 2 
or better (WHO), a white blood count of at least 3,000, and a platelet count 
of at least 100,000.  Patients with an uncontrollable urinary tract infection, 
another malignancy (except skin, excluding melanoma), or expected difficulty 
with followup because of distance or other disease are not eligible.

Expected Enrollment

127 patients will be randomized to each treatment arm (254 patients total); 
with an assumed entry of 175 patients per year, accrual will take 
approximately 1.5 years.

Outline

Patients are treated on Regimen A and then randomized to Arms I and II.
Regimen A:  Single-agent Intravesical Chemotherapy followed by (if required) 
Transurethral Resection (TUR).  Mitomycin-C, MITO, NSC-26980; followed by (if 
required) resection of marker lesion.
Arm I:  Surveillance.  No further therapy.
Arm II:  Maintenance.  Single-agent Intravesical Chemotherapy.  MITO.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Aldo V. Bono, MD, Protocol chair		Ph: 39-332-278-376