Comparative Study of Intravesical BCG Standard Dose Long-Term Maintenance Versus BCG 1/3 Dose Long-Term Maintenance Versus BCG Standard Dose Short-Term Maintenance Versus BCG 1/3 Dose Short-Term Maintenance in Intermediate and High Risk Ta, T1 Papillary Carcinoma of the Urinary Bladder
N/A
85 Years
Both
Bladder Cancer
Trial Information
Comparative Study of Intravesical BCG Standard Dose Long-Term Maintenance Versus BCG 1/3 Dose Long-Term Maintenance Versus BCG Standard Dose Short-Term Maintenance Versus BCG 1/3 Dose Short-Term Maintenance in Intermediate and High Risk Ta, T1 Papillary Carcinoma of the Urinary Bladder
OBJECTIVES:
- Demonstrate that after complete transurethral resection of all papillary tumors, one
third dose BCG (Bacillus Calmette-Guerin vaccine; OncoTICE) is equivalent to full dose
BCG and short term maintenance is equivalent to long term maintenance with respect to
duration of disease free interval, recurrence rate, percentage of patients with an
increase in T-category to greater than T1, and the incidence of carcinoma in situ
during follow-up.
- Demonstrate that one third dose BCG and short term maintenance are associated with
fewer local and systemic side effects.
OUTLINE: This is a prospective randomized study.
At 7-15 days after transurethral resection, patients will begin receiving one of the
following four regimens:
- Regimen 1: One third dose Bacillus Calmette-Guerin (BCG) vaccine plus short term
maintenance. Patients receive a one third dose of BCG instilled once a week for 6
weeks, followed by three weekly instillations at months 3, 6, and 12.
- Regimen 2: Full dose BCG plus short term maintenance. Patients receive a full dose of
BCG instilled once a week for 6 weeks, followed by three weekly instillations at months
3, 6, and 12.
- Regimen 3: One third dose BCG plus long term maintenance. Patients receive a one third
dose of BCG instilled once a week for 6 weeks, followed by three weekly instillations
at months 3, 6, 12, 18, 24, 30 and 36.
- Regimen 4: Full dose BCG plus long term maintenance. Patients receive a full dose of
BCG instilled once a week for 6 weeks, followed by three weekly instillations at months
3, 6, 12, 18, 24, 30, and 36.
The patient is followed every 3 months for the first 3 years, and every 6 months thereafter.
PROJECTED ACCRUAL: 1288 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed transitional cell carcinoma of the bladder of the following
types:
- Multiple (not greater than 10), resectable, T1 or Ta, grade G1-G3
- Solitary T1 GIII tumor
PATIENT CHARACTERISTICS:
Age:
- 85 and under
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Values used to evaluate function may not exceed two times the upper limit of normal
Renal:
- Values used to evaluate function may not exceed two times the upper limit of normal
Other:
- No second malignancy except basal cell skin carcinoma
- Not pregnant or nursing
- No uncontrollable urinary tract infection
- No active tuberculosis
- No HIV antibody
- No leukemia
- No Hodgkin's disease
- No transplant recipients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior treatment with BCG
Chemotherapy:
- No cytostatic agents within the past 3 months
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Dose equivalency with respect to duration of disease free interval, recurrence rate, percentage of patients with an increase in T-category to greater than T1, and the incidence of carcinoma in situ during follow-up
Safety Issue:
No
Principal Investigator
A. P.M. Van Der Meijden, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Jeroen Bosch Ziekenhuis
Authority:
United States: Federal Government
Study ID:
EORTC-30962
NCT ID:
NCT00002990
Start Date:
March 1997
Completion Date:
Related Keywords:
- Bladder Cancer
- stage 0 bladder cancer
- stage I bladder cancer
- transitional cell carcinoma of the bladder
- Urinary Bladder Neoplasms
Name | Location |
|---|
