Description:
This trial is a randomized, multi-center, non-inferiority study comparing observation versus
immediate surgery for low grade, noninvasive bladder cancer.
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
Purpose
This trial is a randomized, multi-center, non-inferiority study comparing observation versus
immediate surgery for low grade, noninvasive bladder cancer.
Trial Arms
Name | Type | Description | Interventions |
---|
Observation | Other | Patients 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 Surgery | Other | Patients 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: | Terminated |
Lead Sponsor: | Vanderbilt University Medical Center |
Last Updated
August 13, 2018