Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation

Study Overview
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Brief Summary
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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.

Detailed Description
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Bladder cancer (BC) is the seventh most commonly diagnosed cancer in the male population worldwide, while it drops to tenth when both genders are considered. Worldwide, the BC age-standardised mortality rate (per 100,000 person/years) was 3.3 for men vs. 0.86 for women.It is more common, especially in developed countries. NMIBC are divided into four groups as low-medium-high and very high risk according to EORTC (European Organization for Research and Treatment of Cancer). Epirubicin is an anthracycline drug used for chemotherapy. Immediate single instillation of epirubicin has been shown to act by destroying circulating tumour cells after TURB(Transurethral Resection of a Bladder Tumor), and by an ablative effect on residual tumour cells at the resection site and on small overlooked tumours.European Association of Urology Guidelines on Bladder Cancer advocates single immediate postoperative intravesical chemotherapy. Early single-dose instillation of epirubicin immediately after transurethral resection was shown to improve recurrence rates in low and intermediate risk groups. Immediate single instillation of epirubicin into the bladder can induce an array of irritative voiding symptoms including dysuria, frequency, urgency, suprapubic discomfort, hematuria and pelvic pain. In some cases, patients cannot tolerate these symptoms and may necessitate removal of chemotherapeutic agent for alleviation. Incomplete instillation leads to an increase in recurrence and progression rates. In this study, continuous infusion of epirubicin into the bladder and instillation of a single dose epirubicin will be evaluated in terms of side effects, tumor recurrence and progression rates.

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

Conditions
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Bladder Cancer, Epirubicin Adverse Reaction, Superficial Bladder Cancer, Tumor Recurrence

Intervention / Treatment
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* Drug: Intravesical Solution
* Drug: Intravesical Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Intravesical Infusion of Epirubicin<br>Patients who received continuous epirubicin infusion into the bladder in the early postoperative period. | Drug: Intravesical Solution<br>* 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.<br>* Other names: Continuous Epirubicin Instillation During the Early Postoperative Period;|
| Sham Comparator: Single-Dose Instillation of Epirubicin<br>Patients who received single-dose epirubicin into the bladder in the early postoperative period. | Drug: Intravesical Solution<br>* 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.<br>* Other names: Single-Dose Epirubicin Instillation During the Early Postoperative Period;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Tumor Recurrence and Progression | Rate of tumor recurrence and progression after intravesical epirubicin therapyepirubicin treatment | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Muscle Invasive Bladder Cancer, Epirubicin, Intravesical Chemotherapy