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

Bladder Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174912
• Other study ID #: 5050
• Status: Completed
• Phase: Phase 4
• First received: May 29, 2017
• Last updated: May 31, 2017
• Start date: January 1, 2007
• Est. completion date: December 31, 2016

Study information

• Verified date: May 2017
• Source: Ankara Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Disease Progression
• Recurrent Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Intravesical BCG instillation
intravesical BCG instillations were done two weeks after transurethral resection of bladder cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Training and Research Hospital

References & Publications (2)

Xu T, Zhu Z, Zhang X, Wang X, Zhong S, Zhang M, Shen Z. Predicting recurrence and progression in Chinese patients with nonmuscle-invasive bladder cancer using EORTC and CUETO scoring models. Urology. 2013 Aug;82(2):387-93. doi: 10.1016/j.urology.2013.04.0 — View Citation

Xylinas E, Kent M, Kluth L, Pycha A, Comploj E, Svatek RS, Lotan Y, Trinh QD, Karakiewicz PI, Holmang S, Scherr DS, Zerbib M, Vickers AJ, Shariat SF. Accuracy of the EORTC risk tables and of the CUETO scoring model to predict outcomes in non-muscle-invasi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence or progression	The primary end point for recurrence was accepted as the occurrence of the first 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