Study Stopped
poor enrollment
Observation Versus Immediate Surgery of Low Risk Bladder Cancer
1 other identifier
interventional
8
1 country
1
Brief Summary
This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2015
CompletedFirst Posted
Study publicly available on registry
March 7, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 19, 2018
CompletedAugust 13, 2018
August 1, 2018
2.3 years
December 7, 2015
August 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Event-Free Survival
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.
12 months
Secondary Outcomes (3)
Proportion of patients with disease progression (either stage or grade)
12 months
Patient-reported Costs
At baseline and 3 months, 6 months, 9 months and 12 months.
Self-reported patient anxiety measured using the EORTC QLQ-NMIBC24
At baseline and 3 months, 6 months, 9 months and 12 months.
Study Arms (2)
Observation
OTHERPatients 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
OTHERPatients 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.
Interventions
Cytology and cystoscopy are done at the same time
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel D. Lee, MD
Vanderbilt University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Instructor
Study Record Dates
First Submitted
December 7, 2015
First Posted
March 7, 2016
Study Start
April 1, 2016
Primary Completion
July 19, 2018
Study Completion
July 19, 2018
Last Updated
August 13, 2018
Record last verified: 2018-08