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Bladder

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

Unique Dataset IDnci-data-397ClinicalTrial.gov IDNCT00445601
DownloadableNo
SponsorSouthwest Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients406RandomizationYesPubMed (PMID)29801011.0
Study PhaseClinical Study Phase IIIBlinding MethodOtherType(s) of dataN/AIntervention TypeN/ADataset TypeOther

Clinical Trial Title

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

Trial Summary and Conditions

RATIONALE: 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.

Data Summary

See data dictionary for more details.

Study Objectives

Primary Compare the efficacy of a single intravesical instillation of gemcitabine hydrochloride vs placebo immediately after transurethral resection of the bladder tumor (TURBT) in preventing recurrence at 2 years in patients with grade 1 or 2 superficial transitional cell cancer of the bladder. Secondary Compare whether a single instillation of intravesical gemcitabine hydrochloride can improve the time to progression to muscle invasive disease vs placebo in these patients. Compare the qualitative and quantitative toxicities of these regimens in these patients. Compare whether treatment with post-TURBT intravesical instillation of gemcitabine vs placebo results in reduced long-term morbidity in patients, as defined by requirement for fewer TURBTs, courses of traditional intravesical therapies, and surveillance cystoscopies over 4 years. Tertiary Assess whether performing a combination of molecular and/or cytologic diagnostic marker tests, including NMP-22 Bladder Chek and BTA Stat every 3 months, can predict recurrence as accurately as cystoscopy alone in these patients.

Outcome Measures

Primary Outcome Measures : Disease Recurrence Rate [ Time Frame: Up to 2 Years ] Percentage of patients who experienced a recurrence of grade 1 or 2 superficial transitional cell cancer of the bladder between the date of registration and 24 months. Disease recurrence considered to occur at date of first observation of recurrent disease subsequently confirmed by biopsy. Patients without recurrence were censored at the time of their last cystoscopy. Secondary Outcome Measures : Rate of Progression to Muscle Invasive Disease at 4 Years [ Time Frame: 4 years ] From date of registration to date of diagnosis of progressive disease. Censor at date of last disease assessment for those without progression. Compare Qualitative and Quantitative Toxicities Between the Treatment Arms [ Time Frame: Up to 4 years after Transurethral Resection of Bladder Tumor (TURBT) ] Number of patients with Grade 3 through Grade 5 adverse events that are related to study drug . Rate of Disease Worsening Over 2 Years [ Time Frame: Up to 2 years ]

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

This 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.

Available Downloads: NCT00445601-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00445601-D2-Data-Dictionary_2.pdf

DATA: NCT00445601-D2-Dataset_2.csv

OTHER: README.pdf

Available Downloads: NCT00445601-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00445601-D1-Data-Dictionary_3.pdf

DATA: NCT00445601-D1-Dataset_3.csv

OTHER: README.pdf