Surgery and BCG in Treating Patients With Bladder Cancer

June 11, 2013 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

1288

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1100
        • Kaiser Franz Josef Hospital
  • Belgium
      • Aalst, Belgium, B-9300
        • Onze Lieve Vrouw Ziekenhuis Aalst
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Brussels, Belgium, 1090
        • Academisch Ziekenhuis der Vrije Universiteit Brussel
      • Ghent, Belgium, B-9000
        • Universitair Ziekenhuis Gent
      • Hasselt, Belgium, 3500
        • Virga Jesse Hospital
      • Kortrijk, Belgium, 8500
        • AZ Groeninge - Oncologisch Centrum
  • France
      • Lyon, France, 69437
        • Hôpital Edouard Herriot
      • Strasbourg, France, 67091
        • Hopitaux Universitaire de Strasbourg
  • Greece
      • Ioannina, Greece, 45001
        • G. Hatzikosta General Hospital
      • Rio Patras, Greece, GR-26500
        • University of Patras Medical School
  • Israel
      • Petah-Tikva, Israel, 49100
        • Rabin Medical Center - Beilinson Campus
  • Italy
      • Milan, Italy, 20033
        • Ospedale di Desio
      • Milano, Italy, 20132
        • Istituto Scientifico H. San Raffaele
      • Novara, Italy, 28100
        • Azienda Ospedaliera Maggiore Della Carita
      • Orbassano, (Torino), Italy, 10043
        • Azienda Ospedale S. Luigi - Universita Di Turin
      • Palermo, Italy, 90145
        • Università di Palermo
      • Pisa, Italy, 56126
        • Universita degli studi di Pisa
      • Turin, Italy, 10126
        • Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino
      • Varese, Italy, 21100
        • Ospedale Di Circolo E Fondazione Macchi
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5211 NL
        • Jeroen Bosch Ziekenhuis
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
      • Amsterdam, Netherlands, 1091 HA
        • Onze Lieve Vrouwe Gasthuis
      • Breda, Netherlands, 4810 EV
        • Amphia Ziekenhuis - locatie Langendijk
      • Leiden, Netherlands, 2300 CA
        • Leiden University Medical Center
      • Leiderdorp, Netherlands, 2350 CC
        • Rijnland Ziekenhuis
      • Maastricht, Netherlands, 6202 AZ
        • Academisch Ziekenhuis Maastricht
      • Nijmegen, Netherlands, NL-6500 HB
        • University Medical Center Nijmegen
      • Rotterdam, Netherlands, 3000 CA
        • University Medical Center Rotterdam at Erasmus Medical Center
      • Rotterdam, Netherlands, 3045 PM
        • St. Franciscus Gasthuis
  • Portugal
      • Amadora, Portugal, P-2700
        • Hospital Desterro
  • Romania
      • Bucarest, Romania, RO 72435
        • Institute of Oncology - Bucarest
  • Turkey
      • Istanbul, Turkey, 81190
        • Marmara University Hospital
      • Izmir, Turkey, 35340
        • Dokuz Eylul University School of Medicine
      • Manisa, Turkey, 45010
        • Celal Bayar University
  • United Kingdom
    • England
      • Leeds, England, United Kingdom, LS9 7TF
        • St. James's University Hospital at Leeds Teaching Hospital NHS Trust
      • Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Pontefract West Yorkshire, England, United Kingdom, WF8 1PL
        • Pontefract General Infirmary
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Gartnavel General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 83 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

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
Dose equivalency in terms of fewer local and systemic side effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: A. P.M. Van Der Meijden, MD, PhD, Jeroen Bosch Ziekenhuis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1997

Primary Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 12, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-30962

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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