Observation Versus Immediate Surgery of Low Risk Bladder Cancer



Status:Terminated
Conditions:Cancer, Cancer, Bladder Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - Any
Updated:8/15/2018
Start Date:April 2016
End Date:July 19, 2018

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


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
We found this trial at
1
site
Vanderbilt University Medical Center
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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mi
from
Nashville, TN
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