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Type(s) of Cancer
Bladder
Study Phase
Phase 3
Study Completion Date
2017-06
NCT00445601Uploaded 01-08-2020
Access via NCI by Request
PDS UID: nci-data-397
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 Information
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
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.
ConditionsBladder Cancer
Intervention TypeDrug: gemcitabine hydrochloride
Other: placebo
Drug(s)Drug: gemcitabine hydrochloride
Total Enrolled406
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionArm I - Experimental
Arm II - Placebo Comparator
Secondary IDS0337
PubMed (PMID)29801011
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years to 120 Years (ADULT, OLDER_ADULT)
Files: NCT00445601-D2
Data DictionaryNCT00445601-D2-Data-Dictionary_2.pdf
DATANCT00445601-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00445601-D1
Data DictionaryNCT00445601-D1-Data-Dictionary_3.pdf
DATANCT00445601-D1-Dataset_3.csv
OTHERREADME.pdf
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