Surgery and BCG in Treating Patients With Bladder Cancer

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002990
• Other study ID #: EORTC-30962
• Secondary ID: EORTC-30962
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: June 11, 2013
• Start date: March 1997

Study information

• Verified date: June 2013
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: This randomized phase III trial is studying four different regimens of BCG and comparing how well they work in treating patients who have undergone surgery for bladder cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1288
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Biological:
• BCG vaccine

Locations

Country	Name	City	State
Austria	Kaiser Franz Josef Hospital	Vienna
Belgium	Onze Lieve Vrouw Ziekenhuis Aalst	Aalst
Belgium	Academisch Ziekenhuis der Vrije Universiteit Brussel	Brussels
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Institut Jules Bordet	Brussels
Belgium	Universitair Ziekenhuis Gent	Ghent
Belgium	Virga Jesse Hospital	Hasselt
Belgium	AZ Groeninge - Oncologisch Centrum	Kortrijk
France	Hopital Edouard Herriot	Lyon
France	Hopitaux Universitaire de Strasbourg	Strasbourg
Greece	G. Hatzikosta General Hospital	Ioannina
Greece	University of Patras Medical School	Rio Patras
Israel	Rabin Medical Center - Beilinson Campus	Petah-Tikva
Italy	Ospedale Di Desio	Milan
Italy	Istituto Scientifico H. San Raffaele	Milano
Italy	Azienda Ospedaliera Maggiore Della Carita	Novara
Italy	Azienda Ospedale S. Luigi - Universita Di Turin	Orbassano, (Torino)
Italy	Universita Di Palermo	Palermo
Italy	Universita Degli Studi Di Pisa	Pisa
Italy	Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino	Turin
Italy	Ospedale di Circolo e Fondazione Macchi	Varese
Netherlands	Jeroen Bosch Ziekenhuis	's-Hertogenbosch
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Amphia Ziekenhuis - locatie Langendijk	Breda
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Rijnland Ziekenhuis	Leiderdorp
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	St. Franciscus Gasthuis	Rotterdam
Netherlands	University Medical Center Rotterdam at Erasmus Medical Center	Rotterdam
Portugal	Hospital Desterro	Amadora
Romania	Institute of Oncology - Bucarest	Bucarest
Turkey	Marmara University Hospital	Istanbul
Turkey	Dokuz Eylul University School of Medicine	Izmir
Turkey	Celal Bayar University	Manisa
United Kingdom	Gartnavel General Hospital	Glasgow	Scotland
United Kingdom	St. James's University Hospital at Leeds Teaching Hospital NHS Trust	Leeds	England
United Kingdom	Freeman Hospital	Newcastle-Upon-Tyne	England
United Kingdom	Pontefract General Infirmary	Pontefract West Yorkshire	England

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Greece,  Israel,  Italy,  Netherlands,  Portugal,  Romania,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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			No
Primary	Dose equivalency in terms of fewer local and systemic side effects			Yes