AzTrials
AzTrials

Bladder CancerPhase 3NCT00002990

Surgery and BCG in Treating Patients With Bladder Cancer

A Phase 3 study testing BCG vaccine in people with Bladder Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 40 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages Up to 85 years
Conditions the study is for
Bladder Cancer
What is being tested?
BCG vaccine
Type of treatment
Vaccines
How many people
1,288 participants
Where
40 sitesin 11 countries
Study dates
Mar 1997to Apr 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

40 sites in 11 countries.

40 sites in 11 countries

Netherlands10 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5211 NL

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, 1091 HA

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Amphia Ziekenhuis - locatie Langendijk

    Breda, 4810 EV

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Rijnland Ziekenhuis

    Leiderdorp, 2350 CC

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202 AZ

  • University Medical Center Nijmegen

    Nijmegen, NL-6500 HB

  • University Medical Center Rotterdam at Erasmus Medical Center

    Rotterdam, 3000 CA

  • St. Franciscus Gasthuis

    Rotterdam, 3045 PM

Other trials in Netherlands

Italy8 sites

  • Ospedale Di Desio

    Milan, 20033

  • Istituto Scientifico H. San Raffaele

    Milan, 20132

  • Azienda Ospedaliera Maggiore Della Carita

    Novara, 28100

  • Azienda Ospedale S. Luigi - Universita Di Turin

    Orbassano, (Torino), 10043

  • Universita Di Palermo

    Palermo, 90145

  • Universita Degli Studi Di Pisa

    Pisa, 56126

  • Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino

    Turin, 10126

  • Ospedale di Circolo e Fondazione Macchi

    Varese, 21100

Other trials in Italy

Belgium7 sites

  • Onze Lieve Vrouw Ziekenhuis Aalst

    Aalst, B-9300

  • Institut Jules Bordet

    Brussels, 1000

  • Academisch Ziekenhuis der Vrije Universiteit Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, B-9000

  • Virga Jesse Hospital

    Hasselt, 3500

  • AZ Groeninge - Oncologisch Centrum

    Kortrijk, 8500

Other trials in Belgium

United Kingdom4 sites

  • Gartnavel General Hospital

    Glasgow, Scotland, G12 0YN

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

    Leeds, England, LS9 7TF

  • Freeman Hospital

    Newcastle upon Tyne, England, NE7 7DN

  • Pontefract General Infirmary

    Pontefract West Yorkshire, England, WF8 1PL

Other trials in United Kingdom

Turkey (Türkiye)3 sites

  • Marmara University Hospital

    Istanbul, 81190

  • Dokuz Eylul University School of Medicine

    Izmir, 35340

  • Celal Bayar University

    Manisa, 45010

Other trials in Turkey (Türkiye)

France2 sites

  • Hopital Edouard Herriot

    Lyon, 69437

  • Hopitaux Universitaire de Strasbourg

    Strasbourg, 67091

Other trials in France

Greece2 sites

  • G. Hatzikosta General Hospital

    Ioannina, 45001

  • University of Patras Medical School

    Rio Patras, GR-26500

Other trials in Greece

Austria1 site

  • Kaiser Franz Josef Hospital

    Vienna, A-1100

Other trials in Austria

Israel1 site

  • Rabin Medical Center - Beilinson Campus

    Petah Tikva, 49100

Other trials in Israel

Portugal1 site

  • Hospital Desterro

    Amadora, P-2700

Other trials in Portugal

Romania1 site

  • Institute of Oncology - Bucarest

    Bucharest, RO 72435

Other trials in Romania

About this study

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

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.

Read the 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.

Conditions
Bladder Cancer
Being tested
BCG vaccine
Keywords
stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCG vaccineBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Dose equivalency in terms of fewer local and systemic side effects

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMar 1997
  3. Primary completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
1,288 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002990
Sponsor's protocol ID
EORTC-30962
Other IDs
EORTC-30962
Status last verified
Jun 2013
First submitted
1 Nov 1999
Last updated
12 Jun 2013
Results posted
No

Publications

  • 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.

    PubMed 26210894

  • 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.

    PubMed 23910233

  • 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.

    PubMed 23141049

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BCG vaccine in people with Bladder Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 40 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Netherlands, Italy, Belgium, United Kingdom, Turkey (Türkiye) and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002990, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in