Study Begin and End Date: January 2013- January 2015
Eligibility Criteria: Men or women with a diagnosis of "superficial" (non-muscle invasive bladder cancer)
Type of Study: Intervention
Funding Source: Cancer Therapy and Research Center
Detailed description of this study
In the U.S., guidelines for following patients with non-muscle invasive bladder cancer indicate that patients should undergo cystoscopy every 3 months for the first 2 years after diagnosis, then every 6 months for the next 2 years, and then yearly. This recommendation is based on expert opinion (Level 4 evidence). The European Association Urology (EAU) recommends a less frequent followup scheme (see Treatment plan below). Although such an approach could considerably decrease costs and burden during the follow-up period by examining patients less frequently, to date these surveillance approaches have never been assessed in a prospective manner. The goal of the study is to compare these 2 different approaches to surveillance for bladder cancer in terms of progression rates, direct and indirect costs, and patient satisfaction.
Title: Phase III blinded study of immediate post-TURBT instillation of Gemcitabine versus Saline in patients with newly diagnosed or occasionally recurring grade I/II superficial bladder cancer.