Clinical trial

Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation in the Early Postoperative Period of Bladder Cancer

Name

BC2021EPI

Description

In this study, the local and systemic side effects, tumor recurrens and progression rates of single or continuous epirubicin instillation during the early postoperative period were investigated in low and intermediate risk non-muscle-invasive bladder cancer.

Trial arms

Trial start

2019-10-01

Estimated PCD

2023-10-05

Trial end

2023-11-05

Status

Recruiting

Treatment

Intravesical Solution

After the Transurethral Resection of Bladder Tumor(TURBT) surgery, 50 mg Epirubicin solution in 150 ml saline was continuously instiled into the bladder for 2 hours. A drainage catheter was closed in order to fill the bladder with epirubicin solution.

Arms:

Continuous Intravesical Infusion of Epirubicin

Other names:

Continuous Epirubicin Instillation During the Early Postoperative Period

Intravesical Solution

After the Transurethral Resection of Bladder Tumor(TURBT) surgery, 50 mg Epirubicin solution in 50 ml saline was instiled into the bladder for 2 hours. A drainage catheter was closed in order to fill the bladder with epirubicin solution.

Arms:

Single-Dose Instillation of Epirubicin

Other names:

Single-Dose Epirubicin Instillation During the Early Postoperative Period

Size

100

Primary endpoint

Rate of Tumor Recurrence and Progression

1 year

Eligibility criteria

Inclusion Criteria: * Low and intermediate risk NMIBC Exclusion Criteria: * High risk NMIBC * Patients who received intravesical BCG * Postoperative gross hematuria * Bladder perforation * Pregnancy * Urinary tract infection * Epirubicin allergy

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-03-28

1 organization

1 product

3 indications

Organization

Ankara Training and Research Hospital

Product

Indication

Indication

Indication