Surgery and BCG in Treating Patients With Bladder Cancer

NCT00002990 | Completed Phase 3

• 1 other identifier: EORTC-30962
• Study Type: interventional
• Target: 1,288
• Locations: 11 countries
• Sites: 40

Brief 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.

Conditions

Bladder Cancer

Keywords

stage 0 bladder cancer; stage I bladder cancer; transitional cell carcinoma of the bladder

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

BCG vaccine BIOLOGICAL

Eligibility Criteria

• Age: Up to 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (40)

Kaiser Franz Josef Hospital

Vienna, A-1100, Austria

Location

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, B-9300, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

Virga Jesse Hospital

Hasselt, 3500, Belgium

Location

AZ Groeninge - Oncologisch Centrum

Kortrijk, 8500, Belgium

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

G. Hatzikosta General Hospital

Ioannina, 45001, Greece

Location

University of Patras Medical School

Rio Patras, GR-26500, Greece

Location

Rabin Medical Center - Beilinson Campus

Petah Tikva, 49100, Israel

Location

Ospedale Di Desio

Milan, 20033, Italy

Location

Istituto Scientifico H. San Raffaele

Milan, 20132, Italy

Location

Azienda Ospedaliera Maggiore Della Carita

Novara, 28100, Italy

Location

Azienda Ospedale S. Luigi - Universita Di Turin

Orbassano, (Torino), 10043, Italy

Location

Universita Di Palermo

Palermo, 90145, Italy

Location

Universita Degli Studi Di Pisa

Pisa, 56126, Italy

Location

Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

Turin, 10126, Italy

Location

Ospedale di Circolo e Fondazione Macchi

Varese, 21100, Italy

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 NL, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, 1091 HA, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Amphia Ziekenhuis - locatie Langendijk

Breda, 4810 EV, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Rijnland Ziekenhuis

Leiderdorp, 2350 CC, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

St. Franciscus Gasthuis

Rotterdam, 3045 PM, Netherlands

Location

Hospital Desterro

Amadora, P-2700, Portugal

Location

Institute of Oncology - Bucarest

Bucharest, RO 72435, Romania

Location

Marmara University Hospital

Istanbul, 81190, Turkey (Türkiye)

Location

Dokuz Eylul University School of Medicine

Izmir, 35340, Turkey (Türkiye)

Location

Celal Bayar University

Manisa, 45010, Turkey (Türkiye)

Location

St. James's University Hospital at Leeds Teaching Hospital NHS Trust

Leeds, England, LS9 7TF, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

Pontefract General Infirmary

Pontefract West Yorkshire, England, WF8 1PL, United Kingdom

Location

Gartnavel General Hospital

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Related Publications (3)

• Cambier S, Sylvester RJ, Collette L, Gontero P, Brausi MA, van Andel G, Kirkels WJ, Silva FC, Oosterlinck W, Prescott S, Kirkali Z, Powell PH, de Reijke TM, Turkeri L, Collette S, Oddens J. EORTC Nomograms and Risk Groups for Predicting Recurrence, Progression, and Disease-specific and Overall Survival in Non-Muscle-invasive Stage Ta-T1 Urothelial Bladder Cancer Patients Treated with 1-3 Years of Maintenance Bacillus Calmette-Guerin. Eur Urol. 2016 Jan;69(1):60-9. doi: 10.1016/j.eururo.2015.06.045. Epub 2015 Jul 23.

  PMID: 26210894 DERIVED

• Brausi M, Oddens J, Sylvester R, Bono A, van de Beek C, van Andel G, Gontero P, Turkeri L, Marreaud S, Collette S, Oosterlinck W. Side effects of Bacillus Calmette-Guerin (BCG) in the treatment of intermediate- and high-risk Ta, T1 papillary carcinoma of the bladder: results of the EORTC genito-urinary cancers group randomised phase 3 study comparing one-third dose with full dose and 1 year with 3 years of maintenance BCG. Eur Urol. 2014 Jan;65(1):69-76. doi: 10.1016/j.eururo.2013.07.021. Epub 2013 Jul 24.

  PMID: 23910233 DERIVED

• Oddens J, Brausi M, Sylvester R, Bono A, van de Beek C, van Andel G, Gontero P, Hoeltl W, Turkeri L, Marreaud S, Collette S, Oosterlinck W. Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guerin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance. Eur Urol. 2013 Mar;63(3):462-72. doi: 10.1016/j.eururo.2012.10.039. Epub 2012 Nov 2.

  PMID: 23141049 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• A. P.M. Van Der Meijden, MD, PhD

  Jeroen Bosch Ziekenhuis

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: March 1, 1997
• Primary Completion: April 1, 2005
• Last Updated: June 12, 2013

Record last verified: 2013-06

Locations

IL (1); NL (10); GB (4); PT (1); GR (2); FR (2); IT (8); AU (1); BE (7); RO (1); TU (3)