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

Sponsor

Ankara Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03174912

Collaborator

(none)

400

Enrollment

Arms

120

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer Disease Progression Recurrent Bladder Cancer	Procedure: Intravesical BCG instillation	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Actual Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Dec 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 Whole patient group (patients not treated with BCG and patients treated with BCG)	Procedure: Intravesical BCG instillation ıntravesical BCG instillations were done two weeks after transurethral resection of bladder cancer
No Intervention: Group 2 Patients not treated with BCG
Active Comparator: Group 3 Patients treated with BCG	Procedure: Intravesical BCG instillation ıntravesical BCG instillations were done two weeks after transurethral resection of bladder cancer

Arm

Intervention/Treatment

Active Comparator: Group 1

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

Procedure: Intravesical BCG instillation

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

No Intervention: Group 2

Patients not treated with BCG

Active Comparator: Group 3

Patients treated with BCG

Procedure: Intravesical BCG instillation

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ankara Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Muhammet Fatih Kilinc, Principal investigator, Medical doctor, Ankara Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT03174912

Other Study ID Numbers:

5050

First Posted:

Jun 5, 2017

Last Update Posted:

Jun 5, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Muhammet Fatih Kilinc, Principal investigator, Medical doctor, Ankara Training and Research Hospital

Additional relevant MeSH terms:

Urinary Bladder Neoplasms

Disease Progression

Study Results

No Results Posted as of Jun 5, 2017