RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Infusing chemotherapy drugs directly into the bladder may kill more cancer cells. It is not yet known if surgery followed by chemotherapy is more effective than chemotherapy alone in treating bladder cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy alone with that of transurethral resection followed by chemotherapy in treating patients who have bladder cancer.
Who can participate
Age range
80 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:
* Cytologically confirmed solitary primary or recurrent papillary transitional cell carcinoma of the bladder
* Ta or T1
* Tumor no greater than 2 cm in diameter
* Negative urine cytology
* No suspicious lesions in bladder requiring biopsy
* No tumors in the prostatic urethra or upper urinary tract
* No prior history of T1 G3 tumors, muscle invasive tumors (T2 or greater), or carcinoma in situ
PATIENT CHARACTERISTICS:
Age
* 80 and under
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* HIV negative
* No active intractable or uncontrollable bladder infection
* No urethral strictures that would preclude endoscopic procedures or repeated catheterization
* No prior or concurrent congenital or acquired immune deficiency syndrome
* No other prior or concurrent malignancy except cured basal cell skin cancer or intraepithelial cancer of the cervix
* No prior or concurrent leukemia or Hodgkin's disease
* No concurrent disease for which general anesthesia is contraindicated
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 12 months since prior BCG vaccine
Chemotherapy
* At least 1 year since prior mitomycin
Endocrine therapy
* Not specified
Radiotherapy
* No prior pelvic radiotherapy
Surgery
* No prior …
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 IDNCT00042887
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC