Observation Versus Immediate Surgery of Low Risk Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Observation Versus Immediate Surgery of Low Risk Bladder Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02700724
• Other study ID #: 151898
• Status: Terminated
• Phase: N/A
• Start date: April 2016
• Est. completion date: July 19, 2018

Study information

• Verified date: August 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: July 19, 2018
• Est. primary completion date: July 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• Immediate Surgery

• Observation

Procedure:
• Surveillance Cystoscopy and Urinary Cytology
Cytology and cystoscopy are done at the same time

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients with disease progression (either stage or grade)	proportion of patients with disease progression (either stage or grade)	12 months
Secondary	Patient-reported Costs	out of pocket medical costs	At baseline and 3 months, 6 months, 9 months and 12 months.
Secondary	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.	At baseline and 3 months, 6 months, 9 months and 12 months.