Back to resultsObservation Versus Immediate Surgery of Low Risk Bladder Cancer
Primary Purpose
Bladder Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate Surgery
Observation
Surveillance Cystoscopy and Urinary Cytology
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer
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
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Observation
Immediate Surgery
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of patients with disease progression (either stage or grade)
proportion of patients with disease progression (either stage or grade)
Patient-reported Costs
out of pocket medical costs
Self-reported patient anxiety measured using the EORTC QLQ-NMIBC24
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.
Full Information
NCT ID
NCT02700724
First Posted
December 7, 2015
Last Updated
August 9, 2018
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02700724
Brief Title
Observation Versus Immediate Surgery of Low Risk Bladder Cancer
Official Title
Observation Versus Immediate Surgery of Low Risk Bladder Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
poor enrollment
Study Start Date
April 2016 (undefined)
Primary Completion Date
July 19, 2018 (Actual)
Study Completion Date
July 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is a randomized, multi-center, non-inferiority study comparing observation versus immediate surgery for low grade, noninvasive bladder cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observation
Arm Type
Other
Arm Description
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.
Arm Title
Immediate Surgery
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Immediate Surgery
Other Intervention Name(s)
Transurethral Resection of Bladder Tumor
Intervention Type
Other
Intervention Name(s)
Observation
Other Intervention Name(s)
Active Surveillance
Intervention Type
Procedure
Intervention Name(s)
Surveillance Cystoscopy and Urinary Cytology
Intervention Description
Cytology and cystoscopy are done at the same time
Primary Outcome Measure Information:
Title
Event-Free Survival
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Proportion of patients with disease progression (either stage or grade)
Description
proportion of patients with disease progression (either stage or grade)
Time Frame
12 months
Title
Patient-reported Costs
Description
out of pocket medical costs
Time Frame
At baseline and 3 months, 6 months, 9 months and 12 months.
Title
Self-reported patient anxiety measured using the EORTC QLQ-NMIBC24
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.
Time Frame
At baseline and 3 months, 6 months, 9 months and 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel D. Lee, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Observation Versus Immediate Surgery of Low Risk Bladder Cancer
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