Observation Versus Immediate Surgery of Low Risk Bladder Cancer

Not Applicable

Terminated

• Conditions: Bladder Cancer
• Interventions: Other: Immediate Surgery; Other: Observation; Procedure: Surveillance Cystoscopy and Urinary Cytology

• Registration Number: NCT02700724
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-07
• Study Start: 2016-04
• Primary Completion: 2018-07-19
• Study Completion: 2018-07-19
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Surgery	Immediate Surgery	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.
Observation	Surveillance Cystoscopy and Urinary Cytology	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	Surveillance Cystoscopy and Urinary Cytology	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.
Observation	Observation	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.

Primary Outcome Measures

Name	Time	Method
Event-Free Survival	12 months	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

Name	Time	Method
Patient-reported Costs	At baseline and 3 months, 6 months, 9 months and 12 months.	out of pocket medical costs
Proportion of patients with disease progression (either stage or grade)	12 months	proportion of patients with disease progression (either stage or grade)
Self-reported patient anxiety measured using the EORTC QLQ-NMIBC24	At baseline and 3 months, 6 months, 9 months and 12 months.	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States