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

Ankara Training and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Bladder Cancer; Disease Progression; Recurrent Bladder Cancer

Treatments: Procedure: Intravesical BCG instillation

Study type: Interventional

Funder types: Other

Identifiers

NCT03174912

5050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 3 patient groups

Group 1

Active Comparator group

Description:

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

Treatment:

Procedure: Intravesical BCG instillation

Group 2

No Intervention group

Description:

Patients not treated with BCG

Group 3

Active Comparator group

Description:

Patients treated with BCG

Treatment:

Procedure: Intravesical BCG instillation