To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action. This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm. To view information about this, please visit the FAQ. If you have any further questions, please contact us.
A 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
Provider Data DescriptionThis dataset will allow users to reproduce the toxicity results reported in the Journal of American Medical Association (Messing et al., JAMA, 2018, PMID referenced above) for trial NCT00445601.
SponsorSouthwest Oncology Group
Data ProviderNational Cancer Institute
Partial set or SubsetN/A
Patients in dataset406
# of Patients Control0
# of Patients ExperimentalNA
Clinical Trials.gov Information
Brief SummaryRATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine directly into the bladder after surgery may kill more tumor cells. It is not yet known whether giving gemcitabine directly into the bladder is more effective than a placebo in treating bladder cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine to see how well it works when given directly into the bladder compared with a placebo after surgery in treating patients with newly diagnosed or recurrent bladder cancer.