Surgery and BCG in Treating Patients With Bladder Cancer
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| ClinicalTrials.gov Identifier: NCT00002990 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : June 12, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bladder Cancer | Biological: BCG vaccine | Phase 3 |
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 (Clinical Trial) |
| Estimated Enrollment : | 1288 participants |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | March 1997 |
| Actual Primary Completion Date : | April 2005 |
- 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
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| Ages Eligible for Study: | up to 85 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002990
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| Study Chair: | A. P.M. Van Der Meijden, MD, PhD | Jeroen Bosch Ziekenhuis |
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00002990 |
| Other Study ID Numbers: |
EORTC-30962 EORTC-30962 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | June 12, 2013 |
| Last Verified: | June 2013 |
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stage 0 bladder cancer stage I bladder cancer transitional cell carcinoma of the bladder |
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Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases |
Urologic Diseases BCG Vaccine Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |