In the Prediction of Recurrence and Progression of NMIBC; EORTC or CUETO or Both?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03174912

Enrollment

400

Registered

2017-06-05

Start date

2007-01-01

Completion date

2016-12-31

Last updated

2017-06-05

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

Conditions

Bladder Cancer, Disease Progression, Recurrent Bladder Cancer

Keywords

EORTC, CUETO, bladder neoplasm, disease progression, recurrence

Brief summary

Investigators aimed to evaluate the performance of The European Organization for Research and Treatment of Cancer(EORTC) and the Spanish Urology Association for Oncological Treatment(CUETO) risk tables on all non-muscle invasive bladder cancer patients(NMIBC), and those not treated with BCG and treated with BCG separately.

Detailed description

Risk tables can be used for the prediction of recurrence and especially progression of nonmuscle invasive bladder cancer .The European Organization for Research and Treatment of Cancer(EORTC) developed a risk table,which provides a scoring system for recurrence and progression risk.The EORTC risk table includes these factors: number of tumors,tumor size,prior recurrence rate,T stage,presence of carcinoma in situ(CIS),and grade for NMIBC patients not treated by maintenance bacillus Calmette-Guerin(BCG) instillation therapy.The Spanish Urology Association for Oncological Treatment(CUETO)later proposed a modified model to be used for patients only treated with BCG instillation.This risk table includes these factors:age,gender,recurrent tumor,number of tumors,T stage,CIS,and grade. There is no risk table that can be used for NMIBC patients treated or not treated with BCG.Should we use the EORTC risk table for patients not treated with BCG and the CUETO table only for those treated with BCG or is one of them sufficient to predict recurrence and progression in all patients?The main aim of this study was to compare the utility of the EORTC and CUETO risk tables in all patients, and separately in patients not treated with BCG and treated with BCG.

Interventions

PROCEDUREIntravesical BCG instillation

ıntravesical BCG instillations were done two weeks after transurethral resection of bladder cancer

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 90 Years

Healthy volunteers

Inclusion criteria

* primary or recurrent bladder cancer * non-muscle invasive bladder cancer * at least 60 months follow-up period if progression was not determined.

Exclusion criteria

* primary CIS, * muscle-invasive disease after second look TUR-BT * non-urothelial carcinoma of the bladder, * concomitant upper urinary tract tumor, * not able to contacted for whatever reason

Design outcomes

Primary

Measure	Time frame	Description
Recurrence or progression	From date of participitant recruitment until the date of first documented progression or recurrence or death from any cause, whichever came first, assessed up to 60 months	The primary end point for recurrence was accepted as the occurrence of the first recurrence or progression

Outcome results

None listed

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