A Prospective Randomized Trial for the Comparison of Two BCG Strains (Bacille Calmette-Guerin) in the Prophylaxis of Papollary Bladder Tumors Stage Ta and T1 and Treatment of Carcinoma in Situ
18 Years
90 Years
Both
Bladder Cancer
Trial Information
A Prospective Randomized Trial for the Comparison of Two BCG Strains (Bacille Calmette-Guerin) in the Prophylaxis of Papollary Bladder Tumors Stage Ta and T1 and Treatment of Carcinoma in Situ
OBJECTIVES: I. Compare two strains of BCG (Connaught vs Tice) in terms of efficacy (yearly
relapse rate) and tolerability in patients with Ta or T1 papillary carcinoma of the urinary
bladder or carcinoma in situ of the urinary bladder. II. Assess the role of prior exposition
to mycobacteria (vaccination/Tbc) for BCG treatment efficacy in these patients. III. Define
the role of fever occurrence as a potential indicator for BCG reactivity in these patients.
IV. Evaluate the p53 status of the resected tumors and IL-8 secretion into the urine as
predictive factors of BCG reactivity in these patients. V. Evaluate disease free interval
and disease free survival, time to progression, and overall survival in these patients. VI.
Evaluate quality of life in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, T stage (Ta vs T1 vs CIS), and BCG immunization status (positive, i.e., greater than
10 mm diameter vs negative-indeterminate, i.e., less than 10 mm diameter). All patients
undergo complete transurethral resection (TURB) to remove bladder tumors. A Mantoux test is
performed. Patients with stage T1 disease undergo a second resection within 2-4 weeks after
initial TURB. Patients are randomized to receive either BCG Onko-Tice (arm I) or BCG
Connaught (arm II). Both arms receive BCG by catheter beginning 2-14 days after the last
TURB. Patients must hold the BCG in the bladder for 2 hours. BCG is instilled once a week
for 6 weeks. Quality of life is assessed before randomization, daily during first and last
weeks of treatment, every 6 months for the first 2 years, and then annually thereafter.
Patients are followed every 6 months for the first 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 300 patients will be accrued for this study within 6 years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed completely resected T1 or Ta papillary
tumors of the urinary bladder TaG2 greater than 2 relapses in 2 years TaG3 unifocal or
multifocal Unifocal primary T1G2-3 after a histological tumor-free second resection If
multiple/multifocal, worst stage and grade AND/OR Histologically and cytologically
confirmed primary or secondary carcinoma in situ of the urinary bladder No persistent T1
disease in second resection No contracted bladder (bladder capacity less than 80 mL) or
bladder irritation within past 5 years No urothelial carcinoma of the upper urinary tract
or the urethra
PATIENT CHARACTERISTICS: Age: 18 to 90 Performance status: WHO 0-1 Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Liver function no greater than 1.5 times
upper limit of normal (ULN) Renal: Renal function no greater than 1.5 times ULN Other: Not
pregnant or nursing Fertile patients must use effective contraception No other concurrent
malignancies except basocellular carcinoma No congenital or acquired immunosuppression
(e.g., HIV, leukemia, lymphoma, transplant recipient) No uncontrollable or untreated
urinary tract infection No chronic recurring bacterial cystitis
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior BCG therapy Chemotherapy: At least 3
months since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 5
years since prior radiotherapy to the bladder Surgery: See Disease Characteristics Other:
No prior tuberculostatic therapy No concurrent local antiseptics or antibiotics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Assess role of prior exposition to mycobacteria
Outcome Time Frame:
6 weeks
Safety Issue:
No
Principal Investigator
George N. Thalmann, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Inselspital, Berne
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 06/98
NCT ID:
NCT00003779
Start Date:
November 1998
Completion Date:
June 2010
Related Keywords:
- Bladder Cancer
- stage 0 bladder cancer
- stage I bladder cancer
- Urinary Bladder Neoplasms
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