Surgery and BCG in Treating Patients With Bladder Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00002990
First received: November 1, 1999
Last updated: June 11, 2013
Last verified: June 2013

November 1, 1999
June 11, 2013
March 1997
April 2005   (final data collection date for 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 [ Designated as safety issue: No ]
  • Dose equivalency in terms of fewer local and systemic side effects [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00002990 on ClinicalTrials.gov Archive Site
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Surgery and BCG in Treating Patients With Bladder Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Bladder Cancer
Biological: BCG vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1288
Not Provided
April 2005   (final data collection date for primary outcome measure)

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
Both
up to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   Belgium,   Italy,   Turkey,   United Kingdom,   Greece,   France,   Portugal,   Romania,   Austria,   Israel
 
NCT00002990
EORTC-30962, EORTC-30962
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: A. P.M. Van Der Meijden, MD, PhD Jeroen Bosch Ziekenhuis
European Organisation for Research and Treatment of Cancer - EORTC
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP