CompletedPhase 3

Surgery and BCG in Treating Patients With Bladder Cancer

Austria, Belgium1,288 participantsStarted 1997-03

Plain-language summary

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 range85 Years

SexALL

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

What they're measuring

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

Trial details

NCT IDNCT00002990

SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2005-04