Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Surgery and BCG in Treating Patients With Bladder Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	85 and under	Other	EORTC-30962 NCT00002990

Objectives

1. 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.
2. Demonstrate that one third dose BCG and short term maintenance are associated with fewer local and systemic side effects.

Entry 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

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

Patient Characteristics:

Age:

• 85 and under

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

1288 patients will be accrued for this study.

Outcomes

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
Dose equivalency in terms of 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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

A. Van Der Meijden, MD, PhD, Study coordinator(Contact information may not be current)		Ph: 31-73-699-2000

Registry Information
Official Title		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
Trial Start Date		1997-03-01
Registered in ClinicalTrials.gov		NCT00002990
Date Submitted to PDQ		1997-03-01
Information Last Verified		2005-02-23

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