RATIONALE: Biological therapies such as BCG use different ways to stimulate the immune system and stop tumor cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with biological therapy may kill more tumor cells. It is not yet known if BCG is more effective with or without mitomycin.
PURPOSE: Randomized phase II trial to compare the effectiveness of BCG plus mitomycin with that of BCG alone in treating patients who have bladder cancer.
Who can participate
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 carcinoma in situ (CIS) of the bladder with urinary cytology
* Primary CIS (no prior history of CIS, papillary, or solid transitional cell carcinoma \[TCC\] of the bladder and no concurrent papillary or solid TCC) OR
* Secondary CIS (detected after complete resection of superficial Ta/T1 TCC of the bladder) OR
* Concurrent CIS (in the presence of superficial primary or recurrent Ta/T1 TCC of the bladder)
* No more than 28 days since prior transurethral resection (TUR) of all visible lesions
* No muscle involvement
* No prior or concurrent upper urinary tract tumors
* No urethral strictures that would prevent endoscopic procedures and repeated catheterization
* No upper urinary tract disease (e.g., vesico-ureteral reflux or massive stones) that would make multiple transurethral procedures risky
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Not pregnant or nursing
* No active tuberculosis (highly positive skin tests allowed if no active disease)
* No disease that would preclude general anesthesia
* No active intractable or uncontrollable infection
* No other prior or concurrent malignancy except cured basal cell skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude study participation
PRIOR CONCURRENT THERAP…
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.
Trial details
NCT IDNCT00023842
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC