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

NCT ID: NCT03174912

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-01
• Study Completion Date: 2016-12-31

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.

Conditions

Bladder Cancer; Disease Progression; Recurrent Bladder Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Whole patient group (patients not treated with BCG and patients treated with BCG)

Group Type: ACTIVE_COMPARATOR

Intravesical BCG instillation

Intervention Type: PROCEDURE

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

Group 2

Patients not treated with BCG

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group 3

Patients treated with BCG

Group Type: ACTIVE_COMPARATOR

Intravesical BCG instillation

Intervention Type: PROCEDURE

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

Interventions

Intravesical BCG instillation

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Muhammet Fatih Kilinc

Principal investigator, Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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-invasive urothelial carcinoma of the bladder. Br J Cancer. 2013 Sep 17;109(6):1460-6. doi: 10.1038/bjc.2013.372. Epub 2013 Aug 27.

Reference Type: RESULT

PMID: 23982601 (View on PubMed)

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.2013.04.007. Epub 2013 Jun 10.

Reference Type: RESULT

PMID: 23759377 (View on PubMed)

Other Identifiers

5050

Identifier Type: -

Identifier Source: org_study_id