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.
Who can participate
Age range
85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
Trial details
NCT IDNCT00002990
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC