NCT00192049.

Study name	A randomized study comparing single agent gemcitabine intravesical therapy versus mitomycin C in patients with intermediate risk superficial bladder cancer
Methods	Open‐label, parallel, randomized study
Participants	Estimated enrollment: 90 participants Eligible ages: > 18 Eligible sexes: both Eligibility criteria Inclusion criteria Histologically verified superficial transitional cell carcinoma of the bladder People with primary or recurrent intermediate‐risk superficial bladder cancer after TUR. People with primary tumor with stage TaG1 with multiple lesions (> 3) or lesions > 3 cm or with TaG2‐3 or T1G1‐2 Participants must not be pretreated with any intravesical immunotherapy (BCG) or chemotherapy Exclusion criteria Time between TUR and start of intravesical chemotherapy will be longer than 4 weeks People who have received previous (BCG) or chemotherapy People with evidence of invasive, locally advanced, or metastatic bladder cancer or with upper urinary tract disease
Interventions	Intervention Gemcitabine: dose and schedule not specified Comparator Mitomycin C: dose and schedule not specified
Outcomes	Primary outcomes Tumor recurrence rate at 12 months Secondary outcomes Tumor recurrence rate in 6 months Disease‐free interval Toxicity profile (local and systemic)
Starting date	December 2003 Expected date of completion: no date given
Contact information	Tel: +1‐877‐285‐4559 or +1‐317‐615‐4559
Notes	Funding source: not reported but probably Eli Lilly and Company Sponsors and Collaborators: Eli Lilly and Company