Observation Versus Immediate Surgery of Low Risk Bladder Cancer

Vanderbilt University Medical Center

Status: Terminated

Conditions: Bladder Cancer

Treatments: Other: Observation; Procedure: Surveillance Cystoscopy and Urinary Cytology; Other: Immediate Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02700724

151898

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

8 participants in 2 patient groups

Observation

Other group

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.

Treatment:

Procedure: Surveillance Cystoscopy and Urinary Cytology

Other: Observation

Immediate Surgery

Other group

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.

Treatment:

Other: Immediate Surgery

Procedure: Surveillance Cystoscopy and Urinary Cytology