Clinical Trials /

Observation Versus Immediate Surgery of Low Risk Bladder Cancer

NCT02700724

Description:

This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.

Related Conditions:
  • Urothelial Carcinoma
Recruiting Status:

Terminated

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Observation Versus Immediate Surgery of Low Risk Bladder Cancer
  • Official Title: Observation Versus Immediate Surgery of Low Risk Bladder Cancer

Clinical Trial IDs

  • ORG STUDY ID: 151898
  • NCT ID: NCT02700724

Conditions

  • Bladder Cancer

Purpose

This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.

Trial Arms

NameTypeDescriptionInterventions
ObservationOtherPatients will not undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Surgery will commence after 12 months of observation or sooner if cystoscopic evidence of disease progression or patient desire.
    Immediate SurgeryOtherPatients will undergo immediate surgery. These patients will undergo surveillance cystoscopy and urinary cytology every 3 months for 12 months. Repeated surgery will be offered for additional recurrences.

      Eligibility Criteria

              Inclusion Criteria:
      
                -  History of low grade, noninvasive urothelial carcinoma of the bladder with a new
                   recurrence that meets the following criteria:
      
                -  total tumor burden ≤3cm in size (multiple lesions permitted)
      
                -  low grade appearance (grade 1 or grade 2)
      
                -  noninvasive appearance (Ta)
      
                -  no history of carcinoma in situ (CIS) or lesions concerning for CIS
      
                -  negative urine cytology (atypical or suspicious for low grade neoplasm are acceptable)
      
              Exclusion Criteria:
      
                -  High grade and/or invasive and/or carcinoma in situ disease
      
                -  Concomitant upper tract urothelial carcinoma
      
                -  Any patient who is pregnant or who may have plans to become pregnant.
      
                -  Positive cytology
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:50 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Event-Free Survival
      Time Frame:12 months
      Safety Issue:
      Description:An event is a complication of any kind, including bleeding requiring blood transfusion, bladder perforation, urinary tract infection, readmission to the hospital, and progression of disease.

      Secondary Outcome Measures

      Measure:Proportion of patients with disease progression (either stage or grade)
      Time Frame:12 months
      Safety Issue:
      Description:proportion of patients with disease progression (either stage or grade)
      Measure:Patient-reported Costs
      Time Frame:At baseline and 3 months, 6 months, 9 months and 12 months.
      Safety Issue:
      Description:out of pocket medical costs
      Measure:Self-reported patient anxiety measured using the EORTC QLQ-NMIBC24
      Time Frame:At baseline and 3 months, 6 months, 9 months and 12 months.
      Safety Issue:
      Description:Measured using the EORTC QLQ-NMIBC24, which is a 24-item questionnaire for patients with superficial bladder cancer. This will be assessed at baseline and every 3 months during the study.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Vanderbilt University Medical Center

      Last Updated

      October 23, 2017