Observation Versus Immediate Surgery of Low Risk Bladder Cancer

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02700724

Enrollment

Registered

2016-03-07

Start date

2016-04-30

Completion date

2018-07-19

Last updated

2018-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Brief summary

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

Interventions

OTHERImmediate Surgery

OTHERObservation

PROCEDURESurveillance Cystoscopy and Urinary Cytology

Cytology and cystoscopy are done at the same time

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026