Overview

This trial is active, not recruiting.

Condition non muscle invasive bladder cancer
Treatments narrow band imaging transurethral resection, standard transurethral resection
Phase phase 3
Sponsor National Institute for Cancer Research, Italy
Start date August 2009
End date October 2011
Trial size 170 participants
Trial identifier NCT01004211, IST-NBI-2009

Summary

To date, fluorescence and narrow band imaging cystoscopy have been tested in many prospective within patient trials but only as an "add on" procedure. This results in a bias that does not allow to determine the real impact of such innovative technologies on bladder cancer management. Hereby we propose the first prospective randomized trial which compares narrow band imaging trans urethral resection as a stand alone procedure versus white light transurethral resection. The primary end point is to assess the recurrence rate of bladder cancer lesions with each treatment modality. The study is designed to disclose an inferior recurrence rate (estimated 10%) in the group treated by narrow band imaging transurethral resection respect to the control group, treated by standard transurethral resection.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients will be submitted to standard white light transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer
standard transurethral resection
Transurethral resection of bladder lesion by mean of standard white light
(Experimental)
The system will be switched to narrow band imaging by simply pushing a button. Transurethral resection and/or cold cup biopsies of all visible lesions known or suspected to be bladder cancer will be performed; 6 random cold cup biopsies from healthy mucosa of bladder trigone, anterior, posterior and lateral walls will be taken in case of a second transurethral resection of newly diagnosed high grade non muscle invasive bladder cancer or of recurrent high grade non muscle invasive bladder cancer.
narrow band imaging transurethral resection
Transurethral resection of bladder lesion by mean of narrow band imaging

Primary Outcomes

Measure
Recurrence free survival rate
time frame: One year

Secondary Outcomes

Measure
Detection rate
time frame: At the end of enrollment
3 years recurrence-free survival rate
time frame: 3 years
3 years progression-free survival rate
time frame: 3 years
3 years overall survival rate
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - All patients must be older than 18 years of age and female patients who are pregnant, breast feeding or not on adequate contraceptive measures will be excluded. - All patients will provide a written informed consent prior to the study. - Consecutive patients from 2 centers in Liguria (National Institute for Cancer Research - Genova and Centro Urologico di Eccellenza ASL 1 - Imperia) with overt or suspected non muscle invasive bladder cancer, including Cis detected by mean of random biopsies or a positive urinary cytology, will be included in the study and randomized to 2 treatments A, B arms. Exclusion Criteria: - Patients with muscle invasive bladder cancer will be excluded. - Patients submitted to immediate radical cystectomy after transurethral resection, irrespective of the clinical stage, will be excluded.

Additional Information

Official title A Phase III Prospective Multicenter Randomized Comparison of Transurethral Resection by Mean of White Light and Narrow Band Imaging.
Principal investigator Paolo Puppo, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by National Institute for Cancer Research, Italy.